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US FDA Update: Is it a Device? After the Fact Design History Files

Co-authored by: Ashley Clark, MS, RAC (US, Medical Device), RQM+ Principal Specialist and Nancy Morrison, RAC, RQM+ Executive Director, Regulatory & Quality Consulting Services and 
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Quality System | FDA

Impact of FDA Adoption of ISO 13485

The FDA’s proposed rule to align its quality system regulation with ISO 13485 has the industry buzzing. What does it mean for medical device and IVD manufacturers? Let’s take a closer look at the proposed changes and what they might mean for manufacturers if they are adopted.
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3 Tips for Efficiently Preparing Your FDA eSTAR Submission

As part of the FDA Reauthorization Act (FDARA) and the Medical Device User Fee Amendments (MDUFA IV) of 2017, the U.S. Food and Drug Administration (FDA) committed to developing electronic submission templates. The intent of these templates is to provide guided submission preparation tools, improve submission consistency, and enhance efficiency in the review process. Since the commitment was announced, the FDA has issued guidance documents on electronic submissions for medical devices, developed the electronic Submission Template and Resource (eSTAR), and launched the voluntary eSTAR Program.
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How to Prepare for COVID-19 EUA or Enforcement Policy Expiration

By: Ryan Randall, Senior Engineer, RQM+ (former FDA CDRH Lead Reviewer) and Kevin Go, Project Engineer, RQM+ (former FDA CDRH Lead Reviewer)
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Software as a Medical Device

Advancements in technology over the past several decades have naturally led to advancements in healthcare. Software as a medical device (SaMD) is particularly poised for growth with one of the latest advancements: the Internet of Things (IoT). Because of this and other factors, the SaMD market is expected to grow at a compound annual growth rate of 21.9 percent from 2020 to 2027, bringing the value to just over $86 million. This growth represents potential lifesaving innovation for providers and patients. However, for manufacturers, especially those that are new to SaMD, it represents new complications in regulatory affairs and risk management.
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FDA CDRH 2021: A Year in Review

By: Kevin Go, Project Engineer, RQM+ (former FDA CDRH Lead Reviewer) and Ryan Randall, Senior Engineer, RQM+ (former FDA CDRH Lead Reviewer). Looking back to 2020, as the COVID-19 pandemic gripped the world, much of the FDA’s focus turned to their response to the public health emergency. CDRH in particular reviewed thousands of emergency use authorization (EUA) applications and worked to facilitate the development and availability of COVID-19 tests and collection kits, personal protective equipment (PPE), ventilators, and other devices. Despite this shift in focus, CDRH also received an increase in “conventional” premarket submissions, such as 510(k)s, De Novos, Premarket Approvals (PMAs), Q-Submissions (Q-Subs), and surprisingly even IDEs. Overall, this amounted to a massive 38% increase to CDRH’s premarket submission workload).1
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News | FDA | EU MDR

Emergency Use Authorization Stories: The Humn Project

As we collectively watch the world struggle to cope with the devastating impacts of COVID-19, the Emergency Use Authorization Act has given the R&Q team opportunities to provide pro bono regulatory guidance to incredible medical device companies that are prioritizing “giving back” to the communities that desperately need the help. --------- The Humn Project During our recent R&Q DEVICE L❤️VE Live!, our subject matter experts discussed the use of the U.S. Food & Drug Administration’s (FDA) Emergency Use Authorization (EUA) process and E.U.’s Medical Device Regulation (MDR) Article 59 to release medical devices needed for the COVID-19 Public Health Emergency.  Check out the on-demand recording of this show here. The U.S.’s EUA allows medical devices that are uncleared or unapproved by the FDA to be used during a national health emergency, in this instance to help prevent the spread of COVID-19. The EUA process is enabled by a Declaration of a Public Health Emergency by the U.S. Department of Health & Human Services (HHS). This process allows for manufacturers of necessary medical devices, in vitro diagnostic devices (IVD), and pharmaceuticals to request an expedited and interactive EUA review to address unmet needs during a health emergency, as we have seen at the global scale during the current COVID-19 pandemic.  This is where Daniel Clark, President of Linear Health Sciences, an Oklahoma-based medical device company and a longtime client of ours, comes in. Typically specializing in the development of products for various types of medical tubing based on proprietary, breakaway safety-valve technology, Clark partnered with his twin brother and younger sister to found the benefit organization, The Humn Project, to develop a UV-C disinfectant light to combat the spread of the devastating virus with a focus on human safety while using the device. “Thanks to the incredible work R&Q has led, we're in a great position currently looking forward to making a fundamental impact on the war against this invisible enemy.” – Daniel Clark, The Humn Project When R&Q heard that Clark and his team were working to bring an open-source, not-for-profit medical device to help prevent the spread of COVID-19 through the EUA, we knew we had to use our team’s expertise to help their efforts at no expense. To assist the project, our team developed a Regulatory Strategy for the device's EUA submission to support labeling and testing plans by compiling and drafting the pre-EUA submission, serving as Regulatory Correspondent with the FDA, and planning to compile the EUA submission in the near future.   We are proud to support remarkable organizations like Humn Project because it is in R&Q’s blood to want to improve the lives of others and we love to back people making a difference in our communities. As Andrea Clark, Marketing and Commercial Partner of Humn Inc., stated: “Humn Project was built out of this need to strengthen public health by building essential products to benefit society at-large. With no other competing interests, Humn Project recognizes inherent disparities within public health and we are working to even the playing field. Currently, this work includes a novel FAR-UVC disinfectant lamp that reduces the spread of germicidal spores. Working with multiple partners, from engineers and testing experts to the R&Q Regulatory experts, we are expediting our MCM through EUA to get this into clinical essential workers’ facilities as quickly as possible." By providing pro bono regulatory support with the EUA process to obtain FDA authorization for Humn Project, R&Q hopes to support its incredible mission and get the device to market quickly and safely. Brian Clark, Humn’s Managing Partner, reiterates the urgency of getting this technology into the hands of those that need it: "Our mission at Humn is to create open-source technology-driven solutions that positively impact communities with efficient scale. We are a benefit organization, and our first opportunity is to commercialize the promising research on the use of Far-UVC as a germicidal disinfectant. Unlike traditional germicidal UV lamps, research indicates this form of UV light can destroy viruses and bacteria, yet still operate safely around humans. The Far-UVC product that we're bringing to market provides direct support for our communities and front-line workers, and benefit the broader health outcomes of our communities." Want to learn more about this topic? Join us on Tuesday, May 26 for R&Q’s May Webinar on the FDA Emergency Use Authorization (EUA) process and EU MDR Article 59 to release devices needed for the prevention and treatment of COVID-19. In this free webinar, we will discuss both emergency application processes, provide answers to the many questions we have received, and share tips and lessons learned from our experiences. Click the button below to learn more and register: If you are looking for help with EUA or other regulatory needs, check out our Regulatory Services page here and contact us today! Our remarkable remote support team is available across all R&Q services and we're ready to answer any questions or concerns you have about how to stay on track for the EU MDR timeline. We can help you navigate the difficult road ahead and we have ample virtual content to keep you in the know. Source: FDA Emergency Situations Medical Devices. Accessed 11 May 2020. 
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MDUFA IV: More Than Just User Fees - FDA Reauthorization Act (FDARA) Passes Senate

Pending the expected signature of President Trump, MDUFA IV will be implemented (along with PDUFA VI and GDUFA II). Passage, including the associated rise in user fees for device manufacturers over the term of the act (FY18-22), was largely expected. Legislative politics involve give-and-take, of course, and increased user fees are reasonably expected to result in systemic improvements in regulation, via industry favored initiatives. FDA has described their “give” portion of the give-and-take process in the document MDUFA Performance Goals and Procedures, Fiscal Years 2018 Through 2022. Unsurprisingly, focus remains on Total Time to Decision metrics for premarket submissions. The linked MDUFA Performance Goals document describes some of the approval or clearance process mechanisms by which improvements in Total Time to Decision might be achieved, as well as various cooperative review mechanisms planned. The Pre-Sub program will be continued, with specific requirements on response timing and meeting date options, and required publication of an updated version of the Request for Feedback on Pre-Market Submissions guidance document. Another provision of the bill requires annual reporting on the previous year’s inspection activities for device and drug facilities, including timing information. Those who have been subjected to lengthy or highly intermittent inspections, or delays in comment on response adequacy, are likely to welcome this additional scrutiny of inspection timelines.
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remediation | FDA | Case Studies | Clinical Evaluation Report | MEDEV 2.7/1

Clarifying the Clinical Evaluation Requirements: A Case Study

About R&Q's Case Studies: We hope this Clinical Evaluation Report case study is valuable to you. Here are our currently available case studies. Subscribing to our blog is the best way to know when future case studies and other resources are available. Questions on this particular subject? Contact us. Challenge Design changes and MEDDEV 2.7/1 rev 4 compliance. The client was implementing multiple design changes on a Class III implantable heart transplant device that required a submission to the Notified Body. As part of this submission, the Clinical Evaluation format needed to be updated to provide clarity and comply with MEDDEV 2.7/1 rev 4. The Notified Body provided feedback on the prior clinical evaluation reports and the client needed assistance in interpreting and addressing the feedback. The primary roadblocks / challenges were interpreting the information provided by the client, identifying and requesting any missing or insufficient documentation, and ensuring the information was comprehensive and understandable to the Notified Body once included in the Clinical Evaluation Report.
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cybersecurity | FDA

The Lowdown on Cybersecurity for Medical Devices

Every one of us has probably either been affected by or knows someone who has been affected by a cybersecurity vulnerability. Some attacks happen for the thrill, some to expose weaknesses between competitors, some for malicious intent, and some for money. We hear of these issues in our daily life - from computer viruses to financial incidents. These types of threats have certainly surfaced in the medical device industry and we need to make sure we are positioned to address these early in the product development process and the post-market space. The ultimate goals are to make sure that a weakness in cybersecurity practices does not affect the functionality of a medical device in a harmful way, and to make sure sensitive patient data is protected as defined by region-specific regulations.
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MDSAP: A Better Inspection Option for Device Manufacturers?

Note: This post is written by Jake O'Donnell, Senior FDA Compliance Principal at R&Q. Jake has more than 20 years of experience working for the FDA. Please join us for a free one-hour webinar on MDSAP, March 28th. Medical device firms, are you looking forward to your next FDA inspection? I have conducted around 400 of them, and I am still trying to think of an instance when the firm was happy to see me. I never took it personally. FDA inspections can be stressful, not to mention they are very expensive and time consuming to support. Furthermore, FDA inspections are often followed by an unpleasant period of uncertainty regarding outcomes and adequacy of responses.
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webinar | audits | FDA | MDSAP

MDSAP: What is it? Is it for me? How will I get it done? [Webinar]

Part of your month, every month: R&Q Intelligence Series webinars are held on the fourth Tuesday of every month. These free webinars from some of the medical device industry's leading-most experts are designed for reporting on and analyzing the top industry trends and topics in the medical device space, each providing key and actionable takeaways for attendees. Slides and recordings will be made available to all registrants. Next up: April 25th, where we'll discuss EU MDR.
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FDA | regulatory | regulatory strategy | draft guidance

Review Controls Applied to Outgoing Data Streams (Because the FDA Might Be)

Medical device manufacturers need to carefully manage several important outward streams of information regarding their products. The regulatory community is generally most familiar with the data stream that relates to obtaining clearance to market devices, which involves communications directly with the FDA. The FDA data stream is customarily well integrated with a firm’s internal regulatory functions of review and approval. However, there are other data streams that are critical to the commercial success of device manufacturers.
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remediation | FDA | 510(k) review | 510(k) | Case Studies | Acquisitions

Acquisition Regulatory Assessments: A Case Study

About R&Q's Case Studies: We hope this Acquisition Regulatory Assessments case study is valuable to you. Here are our currently available case studies. Subscribing to our blog is the best way to know when future case studies and other resources are available. Questions on this particular subject? Contact us. Challenge Investigating acquired products and associated FDA clearances. A client took ownership of numerous products they had obtained through an acquisition. Remediation of the regulatory documents was needed, which included a review and evaluation of the 510(k) products to establish whether or not the current marketed products aligned with the existing FDA clearances. R&Q conducted a 510(k) inventory, which required a significant amount of investigation work to compile a list of all applicable products and associated 510(k) clearances, as well as non-filing justification (NFJ) with regard to design changes.
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FDA | CDER | CDRH | Conferences

The REdI Fall 2016 Conference: Slides and Recordings

The Regulatory Education for Industry (REdI) Conference is an FDA-led forum that brings together the regulatory educators from FDA’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) to provide direct, relevant, and helpful information on the key aspects of drug and device regulations. The FDA holds these conferences only twice a year, which doesn't give medical device companies too much wiggle room when it comes to clearing their busy shedules to attend. So if you missed the conference, R&Q will fill you in!
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warning letter | remediation | FDA | supplier quality | Case Studies

Revamping Supplier Quality: A Case Study

About R&Q's Case Studies: We hope this Supplier Quality Remediation case study is valuable to you. Here are our currently available case studies. Subscribing to our blog is the best way to know when future case studies are available. Questions on supplier quality remediation? Contact us. Challenge The FDA found that not following your procedure is a problem. A multibillion dollar client had a supplier quality process that was not being executed, and was not aligned to regulations (21 CFR 820.50). Suppliers were not being audited at the prescribed regularity, some suppliers rated as low risk were making high risk parts, and others supplied product that did not meet current specifications. The results of an FDA inspection resulted in a Warning Letter that ultimately required third party audit certification. The organization had to react by proposing a plan to halt distribution of two product lines in order to focus on a permanent and comprehensive systemic solution.
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remediation | FDA | Case Studies | CAPA | CAPA remediation

When CAPA Needs a Corrective Action: A CAPA Remediation Case Study

About R&Q's Case Studies: We hope this case study is valuable to you. Here are our currently available case studies. Subscribing to our blog is the best way to know when future case studies are available. Questions? Contact us. Challenge The FDA found problems you didn't think were there. A multibillion dollar client has been marketing product for years with insufficient attention to corrective actions. An analysis of the CAPA records showed 62 open CAPA’s at inception, with an average age of 1.3 years each. The client believed that their process was adequate and therefore did not apply the necessary resources to find a solution. Additional lack of response to FDA Warning Letters resulted in a consent decree, which included the need to improve the CAPA process.
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News | FDA | 510(k) submission | regulatory news | compliance | 510(k)

What You Should Do About the Two New FDA Draft Guidance Documents

It has been a long journey for the FDA to get the new draft guidances published on when to submit a 510(k) for a change to an existing device, and another specific to software changes. But on August 8th, 2016 it finally happened! For those of you who remember the FDA's attempt at updating the 1997 Memorandum in 2011, that draft guidance was met with general industry pushback, congressional input, an FDA report to congress, and now a new draft guidance.
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FDA | Ohio | BioOhio | Regulatory 101 | Regulatory 201

July is a BIG month for R&Q in Columbus, OH

■ ■ ■ Are you an Ohio Bioscience Expo & Showcase attendee here to register for the FDA Regulatory 101 Series? ■ ■ ■   The Ohio Bioscience Expo & Showcase and next FDA Regulatory 101 Series event are on July 27th and 28th, respectively. If you're outside of Columbus but in Ohio, you're likely close, and there's no better time for a road trip than the middle of summer! In fact, here are drive times to Columbus, OH from some nearby cities: Cleveland: 2 hours 9 mins Cincinnati: 1 hr 41 mins Toledo: 2 hr 29 mins Akron: 1 hour 55 mins Dayton: 1 hour 5 mins Canton: 2 hours 2 mins If you can drive to Columbus, OH in a single day, the only thing between you and R&Q on July 27th and 28th is a little open road. Below are all the details you need to know and be sure to save your seat for the FDA Regulatory 101 Series event!
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usability | FDA | human factors | pma supplement | PMA | Case Studies | IEC 62366

FDA Approved: A Human Factors and Usability Case Study

About R&Q's Case Studies: We hope you enjoy our latest case study. View all of our available Case Studies. Subscribing to our blog is the best way to know when future case studies are available. FDA Approved: Creating and Implementing a Compliant Usability Engineering Process Challenge PMA supplement for usability updates not approved. A medical device manufacturer made an update to the design of their Class III device to improve usability and promote proper care and maintenance, and they submitted a PMA supplement to the FDA for the changes. The PMA supplement included a human factors test report from a usability study intended to demonstrate the effectiveness of the changes. The company received a letter from the FDA expressing concern with the level of evidence provided by their human factors testing. The FDA noted that the recent usability study had focused on ease of handling rather than comprehensive safe and effective use, engaged company employees as study participants rather than unaffiliated representative users, and failed to demonstrate that risks related to the most critical aspects of device use had been appropriately addressed in the design and evaluated in testing. The FDA requested that the client conduct another human factors study that addressed these concerns, validating safe and effective use of the device by intended users.
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FDA | PA Bio | Philadelphia | Pennsylvania

Presentation and Networking at PA Bio: Practical Considerations for Avoiding FDA Compliance Problems (BEING RESCHEDULED)

NOTE: This event has been cancelled and is being rescheduled. Organizer Regulatory and Quality Solutions (R&Q) What? A presentation and networking event over lunch at PA Bio: Practical Considerations for Avoiding FDA Compliance Problems, and How to Manage Them If They Arise   In the session you will learn from a former FDA consumer safety officer of 20 years what it takes to proactively improve your systems to avoid problems, and proficiently manage issues if they happen to occur. First-hand experiences of how R&Q helped remediate projects will be shared, and best practice strategic and tactical solutions will be given for how to avoid those situations in the first place. We’ll also investigate emerging oversight trends, common problems, classic times in business cycle when compliance issues arise, and other specific challenges.
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FDA | compliance | UDI | massmedic

MassMEDIC Webinar: A Whole New World of UDI - May 18

If you missed R&Q's Paul Robinson discuss UDI during R&Q's afternoon workshop at BIOMEDevice in April, here's a second chance. A similar presentation and discussion will be offered in conjunction with MassMEDIC on Wednesday, May 18th at 11:30am EST. All the details - including the link to register - are below!
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FDA | compliance | advamed

AdvaMed Webinar: Avoiding and Managing FDA Compliance Problems - Monday, May 9th

Did you miss former FDAer Jake O'Donnell speak about avoiding and managing FDA compliance problems during R&Q's afternoon workshop at BIOMEDevice earlier this week? If so, we have news especially for you: he will be presenting on a similar topic via a webinar on Monday, May 9th at 1:00pm EST. The webinar is presented through AdvaMed, and all the details - including a link to register - are below.
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inspection | fda inspection | FDA | white paper | compliance

NEW White Paper - Practical Considerations for Avoiding Regulatory Escalation: R&Q's Latest, In-Depth White Paper from a Former FDA Consumer Safety Officer

There’s a formula for effectively managing an adverse FDA inspection and the newest R&Q white paper shares it. Learn all the practical considerations for avoiding regulatory escalation from a former FDA Consumer Safety Officer: R&Q's Jake O'Donnell. This is your free, ultimate compliance resource, that you can download now: Managing An Adverse FDA Inspection: Practical Considerations for Avoiding Regulatory Escalation. Preview the first four pages of the 24-page white paper below (click to enlarge), and download it in its entirety at the link! We hope you find the white paper valuable. If you do, be sure to share it with your colleagues and industry peers. Subscribe to R&Q's Blog to stay updated on when new white papers and other content is available.
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FDA | Ohio | BioOhio | Regulatory 101

Announcing the 2016 FDA Regulatory 101 Series

Medical device professionals in Ohio, are you ready? Last year R&Q teamed with BioOhio to present an ongoing series of 101 medical device events throughout the year. Thanks to participation and feedback from ambitious medical device professionals across Ohio - and the support of our gracious hosts - the events were a success. Because of that, we're thrilled to announce we'll be presenting a new and improved program in 2016! One webinar and three in-person events are on tap for this year, with the first - a webinar on medical mobile apps - scheduled for March 3, 2016. Register for the webinar and see the list of upcoming FDA Regulatory 101 events below.
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Medical Devices | News | FDA | R&Q

Announcing R&Q's Newest Senior FDA Compliance Principal: Former FDA Consumer Safety Officer Jake O'Donnell

R&Q is thrilled to announce the newest member of our team. Jake O'Donnell will act as Senior FDA Compliance Principal beginning February 2016. Jake formerly acted as Consumer Safety Officer (CSO) at the FDA for 20 years.
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Q-Sub | FDA | Guidance Document | Pre-Sub | PMA | 510(k) | Pre-Submission

Pre-Submission Program – Final Guidance

On February 18, the FDA issued the final guidance document for the Pre-Submission Program and Meetings with FDA Staff. The Pre-Submission process is a way for industry to get feedback from the FDA prior to the submission of a premarket application (PMA, 510(k), HDE, IDE, de novo, etc.). The sponsor may submit a pre-submission application to the FDA requesting answers to various questions about the marketing application or clinical trial design of their device. The sponsor may request a written response, teleconference, or meeting. The FDA has committed respond to the sponsor within 75 to 90 days.
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guidance documents | 23andMe | FDA | Custom Device Exemptions

Guidance Documents for 2014

In an effort to help get safe and effective medical devices to market more quickly, the FDA publishes a list of proposed guidance documents each year. Here is FDA’s prioritized list of things you can expect to see in 2014:
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FDA | medical device | PMA

Pediatric Subpopulations – Final Rule

On Friday, January 10, 2014 the FDA issued a final rule, which amends the premarket approval (PMA) regulations. The final rule requires “submission of information on pediatric subpopulations that suffer from the disease or condition that a device is intended to treat”. 1 The final rule also defines “pediatric patients” and “pediatric subpopulations”. Per the final rule, “pediatric patients” is defined as a patient who is 21 years old or younger at the time of treatment or diagnosis. “Pediatric subpopulation” means on for the following populations: neonate, infants, children, or adolescents.
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FDA | 510(k) review | 510(k) | CDRH

510(k) Pop Quiz!

How well do you know the logistics of the 510(k) process? Today’s blog is interactive, as well as educational! Take this quiz (no cheating!). Comment on the post to tell me how many answers you got right!
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Diabetes | Artificial Pancreas | FDA | Artificial Organ | PMA

First Artificial Pancreas receives FDA Approval

Upon my nightly adventures of surfing the World Wide Web I came across this article on the Popular Science website announcing the FDA’s approval of the Medtronic MiniMed 530G Insulin pump, praisingly dubbed the first artificial pancreas. The Medtronic device was officially approved by the FDA on September 26, 2013 through the Premarket Approval (PMA) pathway. According to the FDA Approval Letter the MiniMed 530G System is intended for continuous delivery of basal Insulin (at user selectable rates) and administration of Insulin boluses (in user selectable amounts) for the management of Diabetes mellitus in persons, sixteen years of age and older, requiring Insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. The MiniMed 530G System can be programmed to automatically suspend delivery of Insulin when the sensor glucose value falls below a predefined threshold value.
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FDA | medical device | Risk-Benefit | Patient Preference

FDA gives Voice to the People

The Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA) has launched a new initiative targeted at giving the patients a voice in the agency’s decision making process on medical devices. I became aware of this effort by the FDA when recently reading this article which describes CDRH’s program called Patient Preference Initiative.
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class iia | EU | disease management | mobile platform | mobile medical applications | health management | FDA | Substantial Equivalence | verizon wireless | software platform | medical applications | software technologies | medical application

Mobile Medical Applications - Most Reliable Apps, Internationally?

A few notable posts pertaining to mobile medical applications came through my Twitter feed / Inbox recently, so I wanted to share!
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biosense | 21 cfr | fda guidance | mobile medical applications | FDA | medical device | submission type | mobile application | medical applications | regulatory strategy | medical application

Mobile Medical Applications: Make Sure uChek with FDA

The latest mobile medical application news on the industry's collective mind is the issuance of an "It has come to our attention..." letter sent to Biosense Technologies in India, essentially questioning why Biosense has not obtained 510(k) clearance for their uChek mobile application. The device is a mobile medical application for phones that takes a picture of urinalysis strips and compares the color against a standard to make a determination about the status of a patients urine. It also includes a box that controls external light to ensure better quality of the results. From a "fan" standpoint, it's an awesome device and technology. You can see it demo-ed during the TED talk given by the company's CEO.
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software system | regulatory focus | | FDA | FDA website | maude database | software | regulatory | Graematter | Regulatory Intelligence

Regulatory Intelligence

How much time to you spend searching FDA’s website? Looking for predicates, collecting adverse event reports from the MAUDE database, searching for guidance documents, etc. I’m sure I don’t need to dig into the details, you have felt this pain too if you have spent any appreciable amount of time on the Albeit a great source of information, it is a complex web of blue pages, and it takes a very large amount of time (and money!) to find the information you are looking for.
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submissions | FDA | medical device | team members | regulatory | 510(k) | approval time | medicaldevice | customer success | collective experience | regulatory professionals | fda clearance

510(K) Success!

RQS team members pride ourselves on focusing on customer success, and it is with that in mind that I am honored to announce our most recent 510(K) submission was approved this week! We are proud to obtain clearance, but swell with pride because of how we obtained it.
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Medical Devices | medical device industry | FDA | K97-1 | Guidance Document | regulatory | 510(k)

FDA 510(k) Memorandum #K97-1 “Deciding When to Submit a 510(k) for a Change to an Existing Device

The FDA is looking for industry input for the revision of FDA 510(k) Memorandum #K97-1 “Deciding When to Submit a 510(k) for a Change to an Existing Device,” January 10, 1997. This is a critical go-to document for the average Regulatory Engineer, so I have been thinking about what I would change to make it more straight forward. While I can appreciate how difficult it is to make general rules that can apply to an infinite variety of products, there are sections of this document that could certainly be clarified.
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Medical Device Report | Complaint Handling | MedWatch | Complaints | FDA | medical device | MDR | Adverse Event | Post Market Vigilance

Complaint Handling Solutions

In my last post “Who’s watching your MedWatching”, I commented on some of the common issues manufacturers have with their MDR and complaint handling systems. It’s useful to know what people are doing wrong, but I think it is equally important to know how to solve those issues. So in this post, I’m going to point you to two very good resources that I found that give further insight into how to know if you have a problem, and how to fix your system.
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Medical Device Report | Complaint Handling | warning letter | MedWatch | Complaints | FDA | medical device | MDR | Adverse Event | Post Market Vigilance

Who’s watching your MedWatching?

Last year, FDA received almost one million adverse event reports from manufacturers1. Needless to say, the Office of Surveillance and Biometrics has been very busy, and so have manufacturers.
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Biocompatibility | Medical Devices | premarket submissions | G95-1 | standard iso | ISO 10993-1 | FDA | draft guidance document | Guidance Document | biological evaluation | iso 10993 | fda clearance

New Biocompatibility Draft Guidance

FDA issued a new draft guidance document on biocompatibility on Tuesday April 23, entitled Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing. It is intended to replace the ODE General Program Memorandum #G95-1. G95-1 was issued in 1995 in the span of 18 years a lot has changed regarding FDA’s view on biocompatibility.
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harmonized symbols | Medical Devices | medical device labels | standards development organization | labeling | regulators | labeling products | FDA | medical device | labels | regulatory structure | biological product | sdo

Crash Those Symbols - FDA Proposed Rule

Make some noise people - the FDA may be making labeling easier on the medical device and biological product industries by way of harmonized symbols!
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shock | FDA | medical device | tachycardia | fibrillation | electrodes | sudden cardiac arrest | cardiac emergency | electrode pads | heart rhythms | american red cross | aeds

Proposed Order on AEDs

Automated external defibrillators (AEDs) can save the lives of individuals suffering from a cardiac arrest event. Sudden cardiac arrest can happen to anyone and at any time. According to the American Red Cross, over 350,000 people will suffer from sudden cardiac arrest this year.1
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HPFB | medical device companies | wikipedia | money | TGA | regulatory risk | medical device industry | investors | FDA | medical device | ANVISA | engineering projects | open source projects | crowd source

Crowd Source in Medical Devices?

Collaborative development, or for the purposes of this post we'll call it "crowd sourcing", seems to be discussed and used more frequently in the current business environment. Obviously, crowd sourced projects have been around for a long while (Wikipedia is just one well-known example), but other examples are appearing more frequently, including in the medical device industry.
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Japan PMDA | EU | audits | TGA | GHTF | FDA | health canada | quality improvements | iso 13485

FDA’s Guidance Document on Voluntary Submission of ISO 13485 3rd Party Audit Reports

I came across an FDA guidance document – not entirely recent; however, I found it very interesting and worth sharing. It is on voluntary submissions of audit reports done by auditing bodies outside of the FDA.
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trade | MDD | Medical Devices | trade deadline | trade-off | nhl | iso 14971 | risk management | 14971 | FDA | business risk | cmdr

Medical Device Development: Trades

As a somewhat rabid hockey fan there are a few days during the year that are considered sacred holidays: every playoff game, first day of free agency, and the trade deadline. My mind is on hockey because the trade deadline happens to be today. Outside of my insatiable desire to follow all hockey writers in the next 24 hours or so, I find myself thinking about trades in medical devices.
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Excise Tax | budget resolution | bipartisan vote | medical device manufacturers | us senate committee | senate committee on finance | u s senate | FDA | medical device | bipartisan support | government | affordable care | Medical Device Tax | bipartisan

Bipartisan Repeal of Medical Device Excise Tax

Bipartisan support, in today’s world of politics, might seem a little hard to believe. However, the U.S. Senate passed an amendment that repeals the medical device tax last month (Thursday, March 21, 2013). The bill was passed by a bipartisan vote of 79 to 20. 1 This impressive bipartisan support may suggest increasing support for industry.
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3d printing | FDA | medical device | 510(k) | additive manufacturing | oxford performance materials

Medical “Wow”: 3D Printed Skull

Last week I saw several articles published about a new device that is going to shake up the Craniomaxillofacial device market, and the Orthopedic market is next on the list. 3D Printing – chances are you’ve just started hearing about it, mostly concerning gun controls laws for assault rifle cartridges. The other week in Milan the first 3D Printed dress was worn by a model on the fashion runway. 3D printing has the capabilities to change hundreds of industries in my opinion – it’s cheap, relatively easy, and I believe it will be the next revolution in manufacturing. So let’s talk about how the big “wow” in medical devices that occurred last week. Last month the FDA cleared the 510(k) for a 3D printer that prints a human skull. That’s right – and on March 4th, the first one was implanted in a patient who was missing 75% of his skull! The company that developed this technology, Oxford Performance Materials – developed the Class 2 OsteoFab Patient Specific Cranial Device with a digital Computer Assisted Design (CAD) file, by matching the symmetry of the patient’s existing skull, so that the implant is a near-perfect anatomic fit for that particular patient. The skull itself is made of a material called polyetherketoneketone (PeKK) which is radiolucent and demonstrates a modulus of Elasticity similar to bone. The plastic also has key holes through it, which encourage natural bone growth to fill the voids. The company is already working on Orthopedic implants using 3D printing technology for other applications. As I said at the beginning – the implications of 3D printing for medical devices is massive! I can’t wait to see how this will impact the medical device industry. Also, the relatively low cost will allow for more start-up sized companies to utilize the technology, so the door is wide open for innovation that will improve the lives of countless patients. -SJG 3/27/13
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correction | Medical Devices | warning letter | fda inspection | immediate action | FDA | 483 | medical device | corrective action

RQS Feature Article - Successfully Addressing Warning Letters

Regulatory and Quality Solutions is featured in another publication this week! Our President, Maria Fagan, has written an article focused on the top five tips on how to successfully address FDA warning letters. The article is featured in MedCity News and can be found here. FDA warning letters are not to be taken lightly, and the careful handling of them is critical to ensuring your business can move foward to produce safe and effective product. The article provides five great bullet-points of advice on putting your company on the right track with the FDA
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quality agreement | 21 cfr | supplier selection | medical device industry | FDA | supplier management | supplier quality

Getting Control of Supplier Controls

It seems that for one reason or another supplier controls are a requirement that slips through the cracks of even some of the largest medical device organizations. Those of us in the medical device field should know better since 21 CFR Part 820 clearly includes requirements that medical device manufacturers shall have controls over purchased products or services related to medical device being manufactured.
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language development | Medical Devices | cochlear implant | medical technology | cochlear implants | FDA | bionic eye | implant device

Make Sense

My son has a friend that was born deaf. When he was a small child, he had surgery to get cochlear implants. With the implants, he is able to hear. When his younger brother was also born deaf, his parents found that they carried a recessive gene that causes deafness. Both boys were able to receive the cochlear implants. They have developed normal language skills and are able to lead normal lives. Their only restriction is that they cannot play contact sports. I was talking to their mother, and I expressed my awe of medical technology - that deaf people can really hear when wearing the cochlear implant device. She told me that what surprised her most about the Deaf community was that most people who are deaf do not choose to get cochlear implants for their deaf children. There is a pride with being Deaf, and there is a whole close knit Deaf community. They do not see deafness as a handicap, but as uniqueness. Most deaf people are happy in their Deaf community so they want to share it with their children. They do not see deafness as something to be fixed so they usually do not elect to have the surgery. Adults would not benefit as much as children from the implants due to the critical periods for language development being passed. However, some adults have been thankful for the ability to experience hearing with the implants. Therefore, after much resistance, the Deaf community is slowly beginning to accept cochlear implants as a personal choice. I thought that was fascinating.
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standards | european commission | IEEE | MDD | Medical Devices | BSI | medical device field | medical device manufacturer | country code | FDA | ASTM | RTCA

Keeping Up With Regulations

In the medical device field the name of the game is Compliance. The reason for V&V testing is compliance. Prior to distribution you need to provide evidence of compliance. Everywhere you turn there are rules where the medical device manufacturer or distributor must provide evidence of compliance.
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tax payer dollars | medical device manufacturers | fda budget | new medical devices | FDA | advamed | improved products

FDA Budget Cuts This Week

This week, the FDA faces between 5.1 to 5.3% of their budget being cut this week ($210 million of a $4.1 billion budget). I’ll be interested to see what areas of the FDA are impacted by these budget cuts, and what that means for medical device manufacturers. Proposed to be included in those cuts are the user fees medical device & pharmaceutical companies pay the FDA for timely reviews of new medical devices & drugs. Zimmer’s CEO and AdvaMed chairman David Dvorak announced during a conference “The fees voluntarily paid by industry in exchange for meeting certain performance goals are not tax payer dollars and should not be considered in the same light as appropriation funding”. March 1st marks the deadline for when or if these budget cuts will be passed.
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Medical Devices | collaboration | medical device companies | partnership | regulatory science | regulatory pathway | nih | FDA | MDIC | medical device | Innovation | fda regulated products | medical device innovation | governing bodies | innovations

Regulatory Science

I heard an interesting new term today (new to me at least!) that I thought greatly impacts the line of work I am in. Regulatory science is "the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products". This involves not only developing devices and getting them approved by governing bodies but reducing the time and cost it takes to get the device to market.
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QMS | MDD | EU | Canada | Medical Devices | FDA | health canada | 21 cfr 820 | Preventive Action | iso 13485

A QMS Outcast: Preventive Action

We in the medical device industry throw the term CAPA around like it's a word that is common-place in our society (though, here in Pittsburgh, you'll get a lot of confused looks if you tell someone you've opened a CAPA as it is a local performing arts school. That's a strange nightmare with future Broadway stars re-enacting a root cause analysis!).
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medical device industry | taxes | FDA | medical device | public health | govenment | regulatory | 510(k) | CDRH


The FDA received funding to increase its workforce at the CDRH for 2012 and 2013. They have set aggressive goals to improve the turnaround times for 510K approval. They have instituted programs to retain their employees and to increase the reviewer to manager ratio. My colleagues and I were very excited to hear about it. These changes will make things better for the public and smoother for us, especially after these new employees are fully trained. Good news, right?
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quality systems | submissions | guidance documents | good manufacturing practices | FDA | biological product | current good manufacturing practices | combination product | Combination Products

Would you like fries with your Combo meal?

On January 18, 2013, the FDA announced their final rule on current good manufacturing practices for Combination products. These Guidance Documents will tell companies when submissions would be required for any post-approval changes to a combination product. First off, what are Combination products you may ask? It is any combination of a drug, a device, or a biological product. As defined in 21 CFR 3.2, this may refer to two or more regulated components that are physically or chemically combined into a “single” entity, or even a “kit” combination where the before-mentioned are packaged together in a single package. The Combination Products Coalition (CPC) sees this as an excellent move by the FDA, and hopes it will reduce the amount of duplicated work for drug, device, and biological product requirements. But with the new Combination policies, how will this affect current manufacturers? A big long term “pro” might lead to a short term “con” as companies will need to modify their current Quality Systems to accommodate this new rule. Also, what will this do to the number of combination product filings? Will companies take this as a positive, or see it as an additional hurdle? -SJG
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gmp | final rule | FDA | medical device | Pharma | Biologics | Combination Products

Final Rule - Combination Products

Last week, the FDA issued a final rule(1-2) on combination products(3) and the applicable current good manufacturing practice (CGMP) requirements. The final rule actualizes the proposed rule that was issued many moons ago, in September 2009 without significant changes. Four sections comprise the final rule(1-2); §4.1 - Scope, §4.2 - Definitions, §4.3 - Applicable CGMPs, and §4.4 - Single-entity or co-packaged combination products compliance with these requirements.
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13485 | MDD | EU | Quality Management System | Quality System | Product Quality | FDA | medical device | 21 cfr 820 | Joseph Juran | quality

Architect of Quality – Part 2: The Human Dimension

Welcome to the second installment in our blog series featuring Joseph Juran, “Architect of Quality.”1 Today, we’re going to take a deeper look at one of his major contributions – the addition of the “human dimension” to management theory.
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medical device review | FDA | Guidance Document | PMA

Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)

In addition to the Refuse to Accept Policy for 510(k)s Guidance document I discussed in my previous post, the FDA also issued a guidance titled Acceptance and Filing Reviews for Premarket Approval Applications (PMAs) at the same time.
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iPhone | mHealth | mobile medical applications | healthspot | Android | FDA | medical device | Apps | health spot | 510(k) | retinal exam

Mobile Medical Applications - Where do we go from here?

With the recent announcement of 510(k) clearance of a retinal examining attachment and companion app can we now declare the outcry against the FDA finished?
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listing | MDD | EU | Medical Devices | us | gmp | mdufa III | FDA | FDASIA | enforcement actions | registration

Regulatory Intel - Jan. 21, 2013

Wrap-up of a few notable news stories from last week:
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adverse events | hip replacement | surgery | safety communication | FDA | medical device | implantables

Hitting Home

One of the more personal aspects of why I work in regulatory and quality is because of my dad. As a youth, he experienced a hip injury. Combine that with a condition (don't ask - I never remember its fancy medical name) that causes weak capillaries, and that resulted in a "busted hip". Specifically, one that had become so painful in his late 30's he needed a hip replacement.
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quality management | FDA | medical device | 21 cfr 820 | Joseph Juran | quality | iso 13485

Architect of Quality - Part 1

Have you ever wondered where quality management systems came from, or why these infrastructures are designed the way they are? In an effort to explore our roots at RQS, this post is the first in a series about Joseph M. Juran who was a dominant figure in the development and dissemination of quality related concepts that we use in manufacturing today. His autobiography is entitled Architect of Quality1, and his design influence can be seen in many aspects of current quality systems. Let’s take a look at Mr. Juran’s life and contributions to this field.
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preparing for FDA visit | regulatory harmonization | remediation | Australia | FDA | New Zealand | medical device | regulatory news | white paper

Regulatory Intel - Jan. 14, 2013 Quick-Hits

A few quick notes I wanted to post while clearing my inbox of my "informative reading" emails from last week:
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wellness products | watch sensors | mobile medical applications | FDA | medical device | wearable tech

Mobile Medical Applications - Healthcare at CES

So I wasn't kidding last week about wearable tech, which made the biggest splash at CES 2013, an annual consumer electronics expo. Coverage thanks to
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RTA | submission | FDA | medical device | 510(k) submission | 510(k) review | Guidance Document | Refuse to Accept | 510(k)

New "Refuse to Accept" Guidance Document for 510(k)s

There has been much controversy about the new RTA FDA Guidance document titled "Refuse to Accept Policy for 510(k)s". The draft of this guidance was issued for review in August of 2012 and was recently released at the end of that year. However companies are still talking about the changes to the policy and the issues they have with them. As always, the draft guidance document went through the review process where companies could read through the document and provide comments. 
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MDD | EU | FDA | health canada | medical device | cleveland

Mistake, I Think Not!

As a native Clevelander and lifelong (i.e. 47 years) Northeast Ohio resident, I have heard my fair share of “Mistake on the Lake (Erie)” jokes. Yes, it’s true the Cuyahoga River caught fire in 1969, the city has suffered from loss of jobs due to de-industrialization, there have been numerous failed redevelopment efforts, and as far as sports teams go; well, I have yet to see a championship winning team. Jokes aside, I don’t think anyone can argue that the Northeast Ohio region has evolved into a world class leader in medical treatment, education and innovation in the health care industry.
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MDD | EU | label | Regulatory Affairs | RQS | labeling | ifu | FDA | health canada | medical device | user guide | instructions for use | manual

Labels impact the device

During this holiday season, when presents are being packaged and shipped at high volumes, I thought it would be appropriate to talk about the importance of labeling.
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FDA | medical device | regulatory

Call me a (Juris) Doctor!?

I was going to write about China Labeling this week, but I didn't feel like it!
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Biocompatibility | mobile medical applications | Precedence | FDA | Substantial Equivalence | regulatory | 510(k) | quality

Setting Precedence

I sat down tonight, as I do every night that I write a blog post, and I started reading the prior posts from my colleagues. I had every intention of writing on a different topic tonight, but something struck a chord with me when I looked through the blogs. They all had something in common. It’s something that we as regulatory and quality folks struggle with and love at the same time. It’s the topic of precedence.
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Biocompatibility | MDD | EU | Medical Devices | 10993-1 | FDA | health canada | medical device | Medical Device Directive | 10993

Biocompatibility - Simple, Right?

I’ve been working in regulatory for a company in which biocompatibility of device materials has been pretty straightforward and understood by all for many years. Annex A in ISO 10993-1 and FDA General Program Memorandum - #G95-1 is all you need. Check the chart for our device intended use and see that irritation testing, sensitization testing and cytotoxicity testing are required for any new device materials prior to introducing them into the market. Not only did our regulatory folks clearly understand these requirements, but our project teams were also onboard. If engineering wanted to change materials or change the material color or tint, they would contact a toxicologist to perform these three necessary tests. End of story.
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MDD | EU | end user | FDA | health canada | medical device | customer

In Your Face

My teenager works at a local eatery – I thoroughly believe the saying, “A good teenager is a tired teenager”. Besides, there is a lot to be learned from being in the work force.
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medical device innovation consortium | RAPS | off-label promotion | webinar | MDD | EU | mHealth | Medical Devices | mobile medical applications | Training | FDA | scanadu | Pharma | Medical Device Directive | mobile medical apps | US vs. Caronia | Caronia | United States vs. Caronia | qualcomm | x prize

Quick Hits - December 11, 2012

In a bit of a change for today's post, I'm going to highlight some of the big news items that came through my inbox last week:
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mHealth | mobile medical applications | submission | FDA | devices | medical device | Apps | AliveCor | software | predicate | mobile medical apps | EKG | 510(k)

Mobile Medical Applications - Community Bull-Dozers

Well how about that - software developers are making it easy on me to write this series with yet another 510(k) clearance announced this week. The latest in cleared mobile health devices? The AliveCor mobile heart monitor.
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Medical Devices | News | FDA | marketing | off-label

United States v. Caronia

Yesterday, the United States Court of Appeals for the Second Circuit (based in NYC) made a 2-to-1 decision on United States v. Caronia (just one of many criminal cases pertaining to off-label use). This case even contained a supplemental briefing that had the litigants brief the applicability of Sorrell v. IMS Health Inc., 131 S. Ct. 2653 (2011), to the Caronia case. In Sorrell, the Supreme Court ruled that a Vermont statute, which regulated certain speaker and content-based restrictions related to pharmaceutical companies was in violation the First Amendment of the U.S. Constitution.
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iPhone | mobile medical application | mHealth | x prize foundation | tricorder | mobile medical applications | Android | medical apps | FDA | medical device | scanadu | star trek | Apps | Blackberry | 510(k) | qualcomm | iOS

Mobile Medical Applications - Beam Me Up, Scanadu

In a fantastic case of science-fiction-meets-reality, Qualcomm created the X Prize Foundation to challenge developers and innovators to create a Star Trek Tricorder. The prize? $10M!
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quality systems | production quality | design quality | China | FDA | medical device | regulatory | quality

International Spotlight - China

When people ask my opinion of the most difficult country to register medical devices internationally, I would have to say it is China. China is considered to be an “emerging market”- it is getting more and more lucrative to register there as the population gets larger and wealthier. China accounts for 1/5 of the world’s population – about 1.3 billion people. Most marketing departments feel that this huge market is worth the incredible effort that it takes to register medical devices. China registration is therefore usually in the international registration strategies for most large medical device companies.
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me too products | FDA | medical device | success | Innovation | Innovation Pathway

Success as an innovator

How can you be successful as an innovator?
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inspection | warning letter | FDA | 483 | medical device | EIR

Stay out of Frying Pans and Fires!

Quick note today as a training seminar came through my inbox.
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FDA | medical device | comprehensive regulatory assistance | Linkedin

Searching for Medical Device Info

As a recently new professional in the medical device industry, I try to find any tips or tools I can use to gain more knowledge about the industry as a whole. Increasing my general knowledge of the field can only help me when I interact with other professionals. When thinking of what to blog about this week, I was curious how others (young professionals or not) gain more knowledge about their job roles and the industry that they are working in.
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Medical Devices | Halloween | Courses | Training | Learning | FDA

Training and a couple jokes

Trick-or-treating in my neighborhood was moved to Saturday this year because of Hurricane Sandy...therefore I needed a few Halloween jokes to keep me going until this weekend. Here you go:
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medical device review | FDA | medical device | Emergo Group | CDRH

Creating Consistency

One major variable med tech companies are faced with today is the unknown of FDA reviewers. It seems like what works for one company doesn’t necessarily work for the rest. And why is this so?
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occupational safety and health | osha guidelines | MDD | EU | Medical Devices | intuitive responses | design considerations | usability | interaction | occupational safety and health administration osha | environments | FDA | health canada | medical device | occupational safety and health administration | 510(k) | environmental conditions

Mobile Medical Applications: Mobile Medical Device Design

Many medical devices are meant to be used while in mobile situations. These devices could be wearable, carried in a user’s pocket or by hand, pushed like a cart, etc. Users of mobile medical devices expect them to be safe, reliable, durable, and easy to use while in motion or when transported, so let’s look at some design considerations specific to this subset of devices.
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proposals | EU | FDA | CE Marking | European Union | new legislation | FDASIA | September

More changes heading our way?

After a recent statement by the EU health commissioner, it appears that FDASIA's influence may have gone abroad. As the medical device industry gears up and is adapting to the changes that FDASIA brings, it may also have to prepare itself for even more changes heading our way.
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Medical Devices | healthcare innovation | Mobile Health | medical claims | Health IT | Small Business | FDA | algorithm | HIMTA | mobile app regulation | FDASIA | mobile apps

Mobile Medical Applications: Innovation vs. Regulation

Mobile apps are absolutely exploding on the marketplace. It seems like so many business entrepreneurs are focusing on creating new apps that fit various needs such as games, music, organizational purposes and the list goes on. I recently read an article that discussed creating a Mobile Health office within the FDA. Specifically focusing on health alone, there are thousands of mobile apps that focus on counting calories, recording miles walked, and monitoring blood sugar levels.
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iPhone | mHealth | Diabetes | glucose measurements | Mobile Health | mobile medical applications | electronic log book | regulatory department | Android | FDA | medical device | regulatory news | Apps | design engineers | device manufacturers | Glucose Monitor | medical application | fda clearance

Mobile Medical Applications: Falling Star?

I think it's high time we start profiling a few applications that have been approved for use by the FDA, discuss their functionality, and potentially profile the impending issues they may encounter.
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smartphones | iphone 5 | iPhone | Medical Devices | google | application development | dual core | lumia | Mobile Health | mobile medical applications | nexus | health applications | FDA | windows millenium | technical specifications | app development | qualcomm

Mobile Medical Applications: Five or One Galaxies in the Lumia Nexus?

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telemetry | MBAN | FDA | wireless medical device | FCC

Healthcare going mobile

Hospital patients (and hospital staff) no longer have to grow weary of the constant due diligence of power cord avoidance (in fear of tripping on or becoming tangled in cords from the patient monitoring devices). Now, thanks to wireless medical devices, such as portable patient monitors and infusion pumps, more attention can be centered on keeping the hospital gown closed.
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registration database | iPhone | wellness products | jawbone | personal data | myfitnesspal | bodymedia | workouts | FDA | mobile applications | quick scan | fitness and health | barcodes | calorie burn | 510(k) | annoyance | weight watchers | mobile apps | 60 minutes | gray area | electronic logs

Mobile Medical Applications: Wellness Apps

After a small hiatus, the Mobile Medical Apps blog series is back! Today we'll take a look into wellness and weight-loss applications.
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medical images | software developers | submissions | regulatory effort | image viewing software | diagnosis | computer file | ipad | regulatory pathway | submission | FDA | medical device | image credit | barco | press release | calibration | medical applications | 510(k) | princeton | job | fda clearance

Mobile Medical Applications: Visual Calibration

Our third installment of the mobile medical apps series finally features a mobile medical app. This app in particular, the MediCal QAWeb Mobile app, is used to calibrate the screen of an iPad for diagnosis of medical images viewed on said iPad (both versions 1 and 2 according to the article).
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iPhone | MDD | mHealth | Medical Devices | Mobile Health | mobile medical applications | mma | FDA | medical device | mobile medical apps | 510(k)

Mobile Medical Applications: Cyber Security

As with all software and technology, security is, and will always remain, a hot-button topic. It is even a point of contention for computer consumers - Mac vs. PC debates often will focus on how Mac's don't "need" virus protection (which is somewhat of a misnomer, but certainly good marketing).
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iPhone | mobile medical application | mHealth | Mobile Health | mobile medical applications | mma | Android | FDA | Apps | Blackberry | smart phone

Mobile Medical Applications: What's App-ening?

It has been predicted by many technology pundits that smartphones will be in everyone's hands within the next few years. Of course there will be different flavors of smartphones to adjust to different consumer ranges, but the way of the numpad flip-phones will be left to the late 90s and the 2000s.
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