Modernizing the Food and Drug Administration's 510(k) Program: Recent Announcement and Guidance

On January 22, 2019 FDA issued a public notice and opened a request for comments on their Medical Device Safety Action Plan specifically with respect to their proposal to publish a list of cleared devices that use older predicates.

We expect that industry will not support this approach and that FDA will receive a large number of comments to that effect. One argument that will be made is that FDA themselves cleared these devices, knowing the age of the predicate, and they were able to meet FDA’s standard for safety and efficacy. So what message is FDA trying to send to the public?

Another is that this may force manufacturer’s to innovate - even without a market need - and R&D costs that are passed on will increase healthcare costs.

Will this be an appropriate or effective way to shift manufacturers to more recent predicates? What about devices for which there is no recent predicate; why force manufacturers to innovate if the marketplace is not asking for it, driving up healthcare costs unnecessarily? 

Although in many cases a 10 year predicate shoudn’t be the BEST predicate device that you can find.

The request for comments does also ask “Are there other and/or alternative actions we should take to promote the development and marketing of safer, more effective 510(k) devices?” We believe there are, encourage people to provide comments to the FDA.

The reliance of the 510(k) system on predicates certainly has its idiosyncrasies. But it is a system of Congress’s and the FDA’s making. We expect the European MDR to reduce the use of predicates in European medical device clearances, by requiring manufacturers to have full access to the technical file of a comparison device. There may well be merit to this approach: if a manufacturer does not have full information about a predicate, does it really make sense to demonstrate safety and efficacy to something with unknowns? It does appear that FDA is considering changing how predicates are used. But if the regulatory pathway for 510(k)s shifts away from predicates, it must shift somewhere. FDA’s answer today is that somewhere is safety and performance based. 

I had the same feeling about the paragraph above, and “We believe there are” – and whether you were then trying to posit this paragraph as one of those alternative actions?

Also this week, FDA published their final guidance on a “Safety and Performance Based Pathway.” (We discussed the April 2018 draft guidance in an earlier blog post.) This pathway, once FDA has the first applicable device types and performance criteria determined, will implement an expansion of the Abbreviated 510(k) pathway. A predicate will still be needed, but rather than carrying out direct comparison testing against the predicate to demonstrate a device is safe and effective, manufacturers will demonstrate the new device meets FDA-identified performance criteria.

We see this as a positive step - it is reasonable for a manufacturer to know what testing and success criteria a reviewer will expect to see in a submission. That information is not always readily available today. Often manufacturers only have access to the publicly available 510(k) summaries of predicate devices, which provide minimal detail regarding the testing conducted. FDA has promised more device-specific guidance. Regulatory professionals and consultants should not have to ‘use their best judgment’ when planning a clearance pathway. While pre-submissions do provide valuable feedback regarding regulatory strategy, they take time and can lengthen time to clearance.

We hope that establishing objective performance testing criteria will lead to the development of safer and more effective devices than comparison to a predicate. The guidance discusses how "substantial equivalence for certain device types may be demonstrated in a way that is less burdensome, but at least as robust.” However, there is a risk that FDA will require more testing than is required today which will increase the cost of bringing a device to market. We also expect that the device types eligible for which this expanded Abbreviated 510(k) pathway will be limited and the program will grow at a slow pace.

As always, Right Submission is here to keep you up to date on the 510(k) program, support your med device and IVD FDA submission needs, and provide software to get submissions done faster, done smarter.