RQM+ Medical Device and In Vitro Diagnostic Blog

on 22 May 2024 | By Erin Gontang, Senior Consultant, RQM+

The FDA's recently proposed rule on wound care products has sent ripples through MedTech. This rule, if finalized, could significantly impact the classification, labeling, and testing requirements for a wide range of wound care devices.

on 18 May 2020 | By Deven Hennon, R&Q

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...

on 4 August 2017 | By Jake O'Donnell

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...

on 1 August 2017 | By Stephen Biernacki

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...

on 14 July 2017 | By Jyothsna Nunna

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...

on 14 March 2017 | By Jake O'Donnell

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...

on 7 March 2017 | By Stephen Biernacki

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...

on 6 March 2017 | By Jake O'Donnell

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...

on 25 January 2017 | By Stephen Biernacki

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...

on 5 October 2016 | By Kate Keverline

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...

on 12 September 2016 | By Stephen Biernacki

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?...

on 8 September 2016 | By Stephen Biernacki

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...

on 24 August 2016 | By Nancy Morrison, RQM+

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...

on 12 July 2016 | By Stephen Biernacki

■ ■ ■ 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,...

on 22 June 2016 | By Stephen Biernacki

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...

on 11 May 2016 | By Stephen Biernacki

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...

on 28 April 2016 | By Stephen Biernacki

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...

on 15 April 2016 | By Stephen Biernacki

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...

on 13 April 2016 | By Stephen Biernacki

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...

on 8 February 2016 | By Stephen Biernacki

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...

on 6 January 2016 | By Stephen Biernacki

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.

on 21 February 2014 | By Ryan Kasun

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...

on 30 January 2014 | By Ryan Kasun

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:

on 22 January 2014 | By Ryan Kasun

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...

on 10 January 2014 | By Ryan Kasun

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!

on 24 October 2013 | By Ryan Kasun

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...

on 11 October 2013 | By Ryan Kasun

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...

on 22 August 2013 | By Ryan Kasun

A few notable posts pertaining to mobile medical applications came through my Twitter feed / Inbox recently, so I wanted to share!

on 19 July 2013 | By Ryan Kasun

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...

on 14 June 2013 | By Ryan Kasun

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...

on 3 June 2013 | By Ryan Kasun

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.

on 29 May 2013 | By Ryan Kasun

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...

on 23 May 2013 | By Ryan Kasun

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....

on 3 May 2013 | By Ryan Kasun

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.

on 25 April 2013 | By Ryan Kasun

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...

on 24 April 2013 | By Ryan Kasun

Make some noise people - the FDA may be making labeling easier on the medical device and biological product industries by way of harmonized symbols!

on 23 April 2013 | By Ryan Kasun

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...

on 17 April 2013 | By Ryan Kasun

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...

on 5 April 2013 | By Ryan Kasun

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.

on 3 April 2013 | By Ryan Kasun

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...

on 2 April 2013 | By Ryan Kasun

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...

on 28 March 2013 | By Ryan Kasun

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...

on 22 March 2013 | By Ryan Kasun

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...

on 20 March 2013 | By Ryan Kasun

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...

on 14 March 2013 | By Ryan Kasun

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...

on 5 March 2013 | By Ryan Kasun

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...

on 1 March 2013 | By Ryan Kasun

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...

on 26 February 2013 | By Ryan Kasun

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...

on 8 February 2013 | By Ryan Kasun

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...

on 7 February 2013 | By Ryan Kasun

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...

on 31 January 2013 | By Ryan Kasun

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...

on 30 January 2013 | By Ryan Kasun

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...

on 28 January 2013 | By Ryan Kasun

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.

on 28 January 2013 | By Ryan Kasun

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?

on 21 January 2013 | By Ryan Kasun

Wrap-up of a few notable news stories from last week:

on 18 January 2013 | By Ryan Kasun

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...

on 14 January 2013 | By Ryan Kasun

A few quick notes I wanted to post while clearing my inbox of my "informative reading" emails from last week:

on 14 January 2013 | By Ryan Kasun

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.

on 14 January 2013 | By Ryan Kasun

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...

on 20 December 2012 | By Ryan Kasun

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...

on 17 December 2012 | By Ryan Kasun

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.

on 17 December 2012 | By Ryan Kasun

I was going to write about China Labeling this week, but I didn't feel like it!

on 13 December 2012 | By Ryan Kasun

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...

on 12 December 2012 | By Ryan Kasun

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...

on 11 December 2012 | By Ryan Kasun

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.

on 10 December 2012 | By Ryan Kasun

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:

on 6 December 2012 | By Ryan Kasun

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.

on 4 December 2012 | By Ryan Kasun

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...

on 30 November 2012 | By Ryan Kasun

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!

on 29 November 2012 | By Ryan Kasun

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...

on 13 November 2012 | By Ryan Kasun

How can you be successful as an innovator?

on 9 November 2012 | By Ryan Kasun

Quick note today as a training seminar came through my inbox.

on 5 November 2012 | By Ryan Kasun

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...

on 2 November 2012 | By Ryan Kasun

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:

on 8 October 2012 | By Ryan Kasun

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?

on 3 October 2012 | By Ryan Kasun

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...

on 3 October 2012 | By Ryan Kasun

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.

on 1 October 2012 | By Ryan Kasun

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...

on 26 September 2012 | By Ryan Kasun

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.

on 14 September 2012 | By Ryan Kasun

What???

on 11 September 2012 | By Ryan Kasun

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...

on 18 January 2012 | By Ryan Kasun

After a small hiatus, the Mobile Medical Apps blog series is back! Today we'll take a look into wellness and weight-loss applications.

on 2 December 2011 | By Ryan Kasun

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...

on 28 November 2011 | By Ryan Kasun

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...

on 22 November 2011 | By Ryan Kasun

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...