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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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submissions | PMA | 510(k) | advamed

Master 510(k), IDE, and PMA Submissions at AdvaMed's Workshops

Within driving distance to D.C.? There's still time to enjoy a few days there next week and simultaneously hone your submissions skills. The FDA, R&Q, and other talented industry experts courtesy of AdvaMed are offering three workshops dedicated to teaching you the guidelines for successful 510(k), IDE, and PMA submissions. Engage in interactive workshops and hear from industry professionals - such as R&Q's Director of Regulatory of Affairs Nancy Morrison and Senior Principal Advisor Marilyn Waxberg. The AdvaMed events are some of the best in the business, and R&Q is proud to be included as part of the faculty. Read on for details! 
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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What You Should Do About the Two New FDA Draft Guidance Documents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 For those of you who remember the FDA's attempt at updating the 1997 Memorandum in 2011, that draft guidance was met with general industry pushback, congressional input, an FDA report to congress, and now a new draft guidance.
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510(k) submission | 510(k) review | 510(k) | advamed | Workshops | Education

Hear R&Q and Other Industry Experts Discuss 510(k) Submissions at AdvaMed's Workshop In Irvine, CA

Join R&Q's Marilyn Waxberg and Nancy Morrison as they speak along with other industry experts at AdvaMed's 510(k) Submissions Strategy Workshop in Irvine, CA this month. The event is scheduled for two days: February 22-23. Marilyn is R&Q's Senior Principal Advisor and Nancy is Director of Regulatory Affairs. Nancy will be speaking to The Law and Regulations portion of the agenda alongside Pamela Forrest of international law firm King & Spalding. Both Marilyn and Nancy will be leading the Strategy and Planning section on day two.
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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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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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510(k)

510(k)-Exempt Devices

In the FDA-regulated medical device world, there are 3 classifications for medical devices: Class I, Class II and Class III. The FDA (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/default.htm) provides a rather in-depth overview of how to classify a medical device and the requirements behind each product's classification. What may not be evident, or often discussed in common conversation, is that many Class I and some Class II medical devices are 510(k) exempt.
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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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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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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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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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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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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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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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MDUFMA | Small Business | User Fee | Pediatric | PMA | 510(k) | Discount

Deals and Steals

Thanksgiving night I was standing outside in the cold in a line that wrapped halfway around Target. My motivation for this spontaneous Black Friday door-buster shopping was peer pressure, but I was also excited to take advantage of the great prices. Even though I wasn't in the market for a new 50" HD TV for only $350, I still found good deals on some gloves and a new GPS. I took advantage of the deals and steals of the holidays. A good sale is just too hard to pass up.
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Medical Devices | acronyms | Drugs | NDA | 510(k) | Combination Products | Pharmaceuticals

Exploding Bombs?

I have to admit, school doesn't teach you everything. During my first week at RQS, I was working with a client, and we were discussing labeling. She said I needed to get the bomb. Then, if I explode the bomb, everything will be good, and I'll have what I need. I left her office a little bit confused, and then it dawned on me that she did not want me to cause any sort of mass destruction...just to look at the BOM (Bill of Materials). Phew! It's just part of the jargon of the industry. Everyone uses abbreviations, numbers, code names, and pneumonic devices to mean any number of very important things.
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Mission | Medical Devices | Substantial Equivalence | Innovation | Intellectual Property | 510(k)

Navigating Substantial Equivalence

Part of the mission of the CDRH is to ensure medical devices are safe and effective. Based on the risk of the device and the agency’s familiarity with the device type, different levels of evidence are required to convince the FDA that a device is safe and effective.
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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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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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