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medical device | United States

FDA CDRH: What will they do in 2022?

By: Ryan Randall, Senior Engineer, RQM+ (former FDA CDRH Lead Reviewer) and Kevin Go, Project Engineer, RQM+ (former FDA CDRH Lead Reviewer) “It’s tough to make predictions, especially about the future.” Whether baseball Hall of Famer-slash-philosopher Yogi Berra actually said these words or not, the sentiment rings true, as anyone who has tried to predict the course of the COVID-19 pandemic would know. Predicting when the Center for Devices and Radiological Health (CDRH) at the U.S. Food & Drug Administration (FDA) will return back to normal is also no exception. Just as things were starting to look up, the Omicron coronavirus variant has appeared to put another wrench in FDA’s plans. This has delayed FDA’s in-person return to the office and caused FDA to postpone non-mission critical inspections until February 2022.[1] While FDA’s COVID-19 response is still the Agency’s number one priority, there are other important changes to be aware of in 2022.
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medical device

EU MDR Article 61 and equivalence – is there a new way forward?

About this article: Could there be more scope for use of equivalence data under EU MDR than you may have thought? Dr. Amie Smirthwaite, Sr. VP of Global Intelligence & Innovation at RQM+, EU MDR expert, thought leader, and member of the working groups that authored MDCG 2020-5 and 2020-6, has put a lot of thought into MDR Article 61 and the associated requirements around equivalence and sufficient clinical evidence. From the early days of implementing the MDR at BSI until now, five years later, supporting the industry in a consultancy role, Amie has found the wording of this article to be puzzling, creating unnecessary challenges for both notified bodies and manufacturers. Amie and the RQM+ team hope that the position taken in this blog will be food for thought for the European Commission, competent authorities and notified bodies, allowing a bit more flexibility for certifying devices that offer a real benefit to patients.
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medical device | ROW

UK Approved Bodies: on your UKCA mark, get set, go!

The world of medical device regulation has seen immense change in past years. The EU MDR has been at the forefront of every agenda for some time – and the one-year deadline delay provided valuable extra time for businesses to get their act together. That one-year delay also meant that the EU MDR was not implemented into UK legislation before the UK exited from the EU. The UK’s departure from the EU has now added a whole new set of regulatory requirements into the mix. Trading with the UK just got a bit more complicated!
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medical device | ROW

What do we know so far about post-Brexit medical device regulation?

What do we know so far about post-Brexit medical device regulation? With the new European MDR and IVDR regulations at the forefront of every conversation across the medical device industry, the emerging UK regime may have been overlooked as another pending compliance challenge. Yet, the UK’s exit from the European Union (EU) has brought with it a whole host of new regulatory requirements that manufacturers will need to implement if they wish to continue selling their products on the UK market. The Medicines and Healthcare products Regulatory Agency (MHRA) have issued their delivery plan for the UK’s future regulatory framework and have recently launched their public consultation on the future of medical device regulation in the UK. But what do we know so far about the immediate impact on medical device regulation in the UK?
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post market surveillance | medical device | IVD | ROW

Canada Regulations News for Medical Devices and IVDs

In case you missed it, the Medical Device Regulations in Canada quietly got updated in December 2020. The new regulation intends to boost post-market safety and requires manufacturers to submit a summary report, which is similar to the post-market Periodic Benefit-Risk Evaluation Report (PBRER) required for pharmaceuticals in Canada. This new requirement goes into effect on 18 Dec. 2021, which is fast approaching.
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start ups | medical device | startups

R&Q's Christine Santagate Featured in Medical Design & Outsourcing

Staying at the forefront of the medical device industry takes work - a lot of it, in fact. Communication with R&Q's peers in the industry is in large part how our employees do it, and a big part of that is addressing hot topics in the industry. R&Q's own Client Solutions Advisor Christine Santagate was featured in MassDevice's May 2016 issue of Medical Design and Outsourcing in an article titled, "Everything You Ever Wanted to Know about Starting a Medical Device Company." The publication serves as a fantastic how-to guide for startup companies. Here's what she had to say.
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3d printing | medical device | meddevice

The Med Device Industry (and the FDA) Embrace 3D Printing Innovation

Just this week the world's first 3D-printed office opened in Dubai. It took all of 17 days to print a 2,700-square-foot building at half the price of conventional methods. In short, this 3D printing thing has some legs... and we mean that literally, too. 3D printing is definitely a hot topic across the medical device industry. This ground-breaking technology that began in the 80s has advanced into a valuable tool for manufacturers, and even earned itself draft guidance from the FDA earlier this month.
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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 | 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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Canada | change in contract manufacturer | health canada | medical device | license amendment fax back form | registration triggers | registration | change in country of origin

License Amendment Triggers in Canada

Sometimes changes in process can have a dramatic effect on product registration. There are several events that can cause a re-registration of a registered medical device. A new product name, part number, material, manufacturing site, country of origin, business name or manufacturing process are common re-registration triggers. It all depends on the specific regulations of the country involved.
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medical corporation | pittsburgh pa | staying power | fagan | medical device | Pittsburgh Technology Council | quality solutions

Device Idea to Staying Power in the Market

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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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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 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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AGILE | medical device | 62304 | software development

Using AGILE in Medical Device Software Development

In school I was always taught that the medical device development process followed the waterfall model. However since entering the work force I have started to see other methods of development for different types of devices. I have recently been working with software medical devices. My client is constantly updating the software device by either adding new features or fixing defects. There is continuous development which means frequent pushes to market for this standalone software medical device. Because of this continuous improvement and continuous innovation....is the waterfall approach the best for development or will it hold up the innovation process?
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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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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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mammogram | Medical Devices | mammograms | usability | medical device | breast cancer screening | human factors | regulatory | Women in Bio | quality | Breast Cancer

Human Factors

Recently I had to get my annual mammogram. They were running behind like doctor’s offices sometimes do - there were seven women in dressing gowns in the waiting room with me. After a few awkward moments, we all started to talk to each other. Every single one of the ladies talked about how they hate to come and get their annual mammograms. They talked about the pain of it, joked about the embarrassment of it - there was even a suggestion that they should serve wine in the waiting room instead of coffee. But each also showed a deep appreciation for the necessity of breast cancer screening - telling stories of aunts and mothers who were saved by it. Finally one woman told us that she was 39 when a mammogram detected her breast cancer for the first time. She was able to get minor surgery and was put on a regimen of annual mammograms. Six years after, she got breast cancer again. Again the mammogram was able to catch it early. She said she was now 57 years old and she felt like she owed 18 years of life to her doctor who suggested she get a mammogram at 39. There is no doubt about it; mammograms save people’s lives.
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investors | patent | patent application | first to file | medical device | patent office | law | Innovation | first to invent | us patent law | patent system

Patent Law Changes

For over 200 years, the US has operated under a “first to invent” rule. This means that if two innovators independently submit a patent for the same exact invention, the person who can prove that they invented it first is the one who is awarded the patent.
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ergonomics society | alarms | usability | false positives | alarm systems | medical device | iec 60601 | human factors

An Alarming Trend

If you’ve ever spent any appreciable amount of time in a hospital or other medical care facility, you may have been driven temporarily insane by the never-ending chorus of medical device alarms. I was recently reminded of a few nights I spent in the hospital with my dad a year or so ago. Just when I thought I was drifting off to sleep, one of the infusion pumps delivering his pain medication would go off and wake both of us up. This got me thinking about alarm fatigue, and the drain that so many medical device alarms must have on medical staff, not to mention patients and family.
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audit | medical device

Audit Training

I recently had the opportunity to receive some training in auditing of medical device companies. In this training I was able to gain experience from an auditor's perspective as well as an auditee's perspective on how an audit is performed. This training was important to me because auditing is a huge part of the regulated medical device industry whether it is internal audits, audits from notified bodies or the FDA coming in and auditing products and processes. One of my goals during the training session was to see from both the auditor and auditee's perspective how questions are asked and then answered as well as what specifically an auditor looks for and how they write up findings or observations.
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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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device submissions | medical device | american medical association | pubmed | Guidance Document | pma supplement | medical product | draft guidance | journal of the american medical association

Open Comments are Not Left Unheard!

Some may think the FDA does not take what industry has to say to heart or feel that there is no point in commenting on a proposed rule, because their feedback is left unread.
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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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Da Vinci | medical device industry | technology | medical device | technology advancements | surgery system | Robot-assisted | Intuitive

Technology Overkill?

Over the past few years, there have been some really great technologies that have changed the way we live our lives. Smartphones are the easiest example. Life would be a lot different if I didn’t have instant access to my e-mail, the weather, the spinning schedule at my gym, or Fruit Ninja. While many technology advancements have certainly improved the way we live our lives, there are some that may be technology overkill. Like a washing machine or dryer that you can remotely monitor and control from your PC, or a Mercedes Benz that can shift the direction of your headlights away from the oncoming traffic. A washing machine that you turn on yourself, or headlights that point straight ahead are alternative options that accomplish the same end goal, they just do it much more cost-effectively than the high-tech ways. Don’t get me wrong, the development and engineering that went behind these things is super impressive, but sometimes, the bang is just not worth the buck.
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adverse events | Medical Devices | quality engineering | Regulatory Affairs | design quality | mhra | risk management | medical device | maude database | design dossier

Regulatory Thoughts

Up until the time when I joined the RQS team in November all I had ever truly worked on was Quality. Coming out of college I worked for a plastics bottling manufacturer in process development and quality control. My next job was design V&V closely followed by design quality engineering and risk management. My exposure to regulatory affairs was at an arms length. I was always the person on the other end of a conversation where I was the one being told that I need to do something in a particular way because the regulations said so.
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new medical devices | medical device industry | medical device | regulation | sensors | innovations | medical breakthroughs

New Medical Devices Coming Soon to a Hospital Near You

Recently I came across a FoxNews article (‘Medical breakthroughs on the horizon for 2013’ by Dr. David Samadi) that got me excited. The reason why I pursued the medical device industry was to be in a field that impacted people; a field that matters. I don’t care who you are – anyone with a loved one who has ever been sick, or needed surgery, etc. has been impacted by medical devices in some way. What impresses me is how medical devices are always pushing the boundaries.
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standards | MDD | iso 14971 | medical device | Medical Device Directive | ISO | iso 13485

Making Sense of Standards

You may have heard that last year there were two new releases of EN standards: EN ISO 14971:2012 and EN ISO 13485:2012. What does this mean to you? What are the changes? How much does this affect the way you do business? Compliance to standards can be somewhat overwhelming. After a little digging into the changes to EN ISO 14971 and EN ISO 13485, hopefully I can provide you with a little clarity.
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medical device industry | taxes | FDA | medical device | public health | govenment | regulatory | 510(k) | CDRH

Headaches

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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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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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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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 CNET.com.
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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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biodegradable circuits | ingesting medical device | medical device | biodegradable | circuits

Biodegradable Circuits

When I first heard the words “biodegradable” and “electronic devices” together, especially in the context of nanotechnology and the medical field, the idea smacked ever so slightly of science fiction. You know, the sort of advancement that belongs in an era of teleportation and colonies on other planets. Apparently, the science is real and also really cool. A team of researchers from the University of Illinois, Tufts University, and Northwestern University have developed a family of biodegradable electronics that dissolve completely in water and other similar fluids. Silicon, magnesium, and magnesium oxide are the standard ingredients for the circuitry, and an engineered silk barrier protects the materials from water so they don’t begin breaking down right away. The circuits are ultrathin, only a few nanometers thick, and the engineers can control how quickly the device breaks down by changing the thickness of the materials. They can also control the length of time before the device begins to biodegrade by modifying the structure of the protective silk layer. (For more on cool new uses for silk in nanotechnology, check out Rebecca’s earlier article.)
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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 | 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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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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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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medical device | Innovation | Cleveland Clinic

Rethinking Innovation

One of my favorite topics about the medical device industry and technology in general is innovation. Rebecca's post last week discussed the Medical Innovation Summit - "Innovative to the Bone" hosted by the Cleveland Clinic. Although I was unable to attend the event, I did find an interesting article that discussed the current status of innovation as well as what the future looks like in this area.
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magnetic resonance imaging | medical imaging | mobile medical applications | mma | MRI | medical device | computed tomography | iPad medical apps | picture archiving communication system | teleradiology | mobile medical apps | aycan mobile | PACS

Mobile Medical Applications - Aycan 510(k)

To continue our product highlights within mobile health, we turn to Aycan's "Aycan Mobile" product which received clearance on September 12, 2012. A picture of its use on an iPad is shown on their website.
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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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iPhone | touchscreen | mobile medical applications | usability | buttons | medicaldevices | Android | medical device | medicaldevice

Mobile Medical Applications - Difficult Usability?

The topic of this week's post was a bit more challenging than normal. Ever since my inadvertent "reboot" of the Everyday Usability series, my brain was stuck in that frame of mind. Even today I struggled to break my mind from it.
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literature review | medical device

Conducting a Literature Review

One issue that came up last week with a client was how to conduct a literature review and how important literature reviews were. I have experienced in some cases, companies that have a lot of man power behind the reviews but these companies do not have solid criteria for focusing their searches. I have experience with other companies that do not necessarily have enough people or time to solely focus on conducting a literature review, yet they have created great search acceptance criteria. So which is better?
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MDD | EU | Europe | medicaldevices | medical device | European Union | Medical Device Directives | IVD | medicaldevice | active implantable medical device

Overview of New Medical Device Regulations in Europe

This week my inbox was flooded by notifications of a great blog post from the Emergo group, outlining the changes set to occur to the medical device regulations in Europe. Changes such as:
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Everyday Usability | landfill | usability | medicaldevices | Starbucks | medical device | trash | green movement | medicaldevice | recycling

Blast from the Past - Everyday Usability

I couldn't resist the urge to post another picture in the Everyday Usability series after seeing this:
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mHealth | idiom | mobile medical applications | mma | medicaldevices | medical device | Apps | titanic | medicaldevice

Mobile Medical Applications: Titanic Chairs

I've often believed that the number of idioms and quirky phrases describing a particular characteristic, event, or circumstance is mostly equivalent to its frequency in everyday life.
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medical device | compliance | standard

Keeping up with Standards

With recent clients I have been dealing more and more with new standards coming out or revisions being made to standards. This has got me thinking a lot about how to keep up with current standards. What is the best way of being notified of new releases of standards as well as interpreting and then implementing those standards?
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mHealth | Medical Devices | mobile medical applications | Windows 8 | mma | medicaldevices | Android | medical device | mobile medical apps | medicaldevice | iOS

Mobile Medical Applications: Whale Cupcake

A good friend of mine in high-school was trying to understand the definition of a "hyperbole". Now, if Google would have been sophisticated enough at the time to include the "define:" feature, it would have returned the following for hyperbole: Exaggerated statements or claims not meant to be taken literally. Instead, I got the following nugget of awesome: So it would be like saying I ate a whale, when I really ate a cupcake? I think my response was laughter and "Sure, something like that..."
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medical device

Medical Devices in Different Markets

I recently took a two week vacation to South Africa traveling to Cape Town, Prince Albert and various parts of the northern Western Cape. It was an absolutely amazing trip with many memories of time spent with my family. Traveling to a foreign country has shown me a lot of new things about the world and the various cultures and lifestyles that people experience from the food, music, and climate to politics, religion and available healthcare.
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Excise Tax | medical device | Tax | Affordable Care Act | Medical Device Tax

Medical Device Tax: Funding Healthcare for Millions

In the second of the two part series, we'll review support of the 2.3% tax of the medical device industry to go into effect on January 1, 2013. Earlier this week, I outlined why the industry sees this tax as an enormous burden and described actions already being taken to off-set the cost of the tax (the overwhelming sentiment toward the tax). In all fairness, we need to consider why the tax was implemented, and what greater good it is serving.
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Kickstart | Veteran's Affairs | medical device | orthosis | Cleveland Clinic | Cadence Biomedical

Now that’s some real horse power

Our neighbors located up the street from our Cleveland, OH location, at the Cleveland Clinic, have recently helped develop horse power into a whole new meaning. A Cleveland Clinic researcher found that one reason horses are more efficient at walking and running than humans, is because of the extremely long tendons in their legs. The Cleveland Clinic researcher then took the horse’s anatomy and applied it to help develop an orthosis device, fittingly called Kickstart, which helps patients with impaired walking. The technology behind Kickstart was licensed to Cadence Biomedical and hit the market in September.
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Excise Tax | medical device | Tax | Affordable Care Act | Medical Device Tax

Medical Device Tax: Windfall or Pitfall?

Thanks to Sherri's earlier post, we've begun to explore the landscape of the medical devices industry in reaction to the 2.3% tax on revenue for medical device companies as a result of the Affordable Care Act. The tax is being implemented in part to fund the estimated 30 million additional Americans that will be provided with health coverage.
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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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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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nanomaterials | medical device industry | medical device | nanotechnology | FDASIA | med-tech industry

Nano-what? Nanotechnology.

Over the past 50 years, the advancement of technology has been beyond incredible. Although, we are not zipping around in flying cars, fearing the dreaded encounter with a hoverboard gang, or living amongst cyborgs, we are witnessing things never before thought possible. Such innovations include robotic performed surgeries, implantable drug-eluting stents (DES), and the ability to “print” skin grafts.
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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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