Medical device manufacturers make changes to existing products and manufacturing processes all the time. But how does the manufacturer decide when to handle that change internally, using a letter-to-file, versus notifying the FDA via a special 510(k) or PMA supplement?
On Oct. 1, the FDA's revised version of the guidance document Refuse to Accept Policy for 510(k)s (RTA) goes into effect. While the RTA rate has been in decline, 69 percent of 510(k) applications submitted between January and June of this year were rejected the first time out of the box. Many of those were rejected based on shortcomings in the RTA checklist — something that should never happen. While the new guidance is applicable specifically to 510(k) submissions, the general principles are applicable to all medical device regulatory submissions.
Risk assessment and risk management in the medical device industry typically start with a brainstorming session. Members of the product development team sit down together, start randomly rattling off risks as they come to mind, and write them all down. It is an almost haphazard process and, in the end, you can never be certain you have captured all the potential risks. To help offset the inherent shortcomings of brainstorming sessions, I recommend a more systematic, engineering-minded approach.
The mere thought of interacting with FDA causes a great deal of stress for some medical device manufacturers. Right or wrong, the agency has developed a reputation for being less than accommodating and communicative over the years (though there are signs that its chilly demeanor is starting to warm). Plus, it’s easy to cast the relationship between industry and FDA as inherently adversarial; after all, the regulator casts a rather long shadow over the pathway to market for new medical devices and diagnostics.
Reprocessing has taken center stage in the medical device industry over the past two months, thanks to several high-profile “superbug” outbreaks that were linked to the use of contaminated duodenoscopes (a type of endoscope) at two prominent U.S. hospitals. How did we get to this point as an industry? What can we do to ensure this type of problem doesn’t occur with our medical device designs? And what will the future hold when it comes to the reprocessing of medical devices? Let’s explore these (and other) questions related to this significant and timely issue.
So, you’ve determined the appropriate FDA classification for your medical device or diagnostic product, and now it’s time to select a premarket submission pathway. Pretty straightforward decision, right? If your technology is substantially equivalent to a currently marketed device (or predicate) then you file a 510(k). If not, or if your device falls into Class III, then the premarket approval (or PMA) is the route for you. Well... not necessarily.
Without a doubt, one of the most common questions I get from medical device manufacturers is, “How early in the medical device development process should we talk to FDA?” In my 20+ years of experience bringing medical devices to market, I have found that it is never too early to talk to FDA. There are, however, several caveats to the previous statement, as I will explain.
When it comes to design controls, one of the most common problems I see medical device companies make is focusing on following the regulation rather than understanding its intent. In other words, they focus on what the words say, and not what the regulation is trying to accomplish.
Why should we have to wait until a patient swallows a pill to find out if it works on them? This is something that’s always bothered me about the way we practice medicine. If you think about it, it really makes no sense. I would like to be able to know, to a very high degree of certainty, whether or not that pill will work in that patient before they put it in their body. Herein lies the promise of companion diagnostics.
Part 1 of this article sought to provide a better understanding of the concept of substantial equivalence in premarket notifications, more commonly known as 510(k)’s, using easy-to-understand metaphors. We also looked at recently issued CDRH draft guidance concerning different technological characteristics of a 510(k) submission. In Part 2, we move on to another piece of recent CDRH guidance, this one dealing with the controversial topic of split predicates.
The two most important components of a successful 510(k) submission are the substantial equivalence argument and the risk mitigation strategy. This two-part article will focus specifically on the substantial equivalence component, explaining what it is and how to establish it. It will also explore two recently issued FDA guidances related to substantial equivalence, and how they should influence your regulatory strategy.