Gottlieb’s Departure Should Not Siderail Reforms to 510(k) Pathway

March 15, 2019

The unexpected resignation of Dr. Scott Gottlieb from the Food and Drug Administration last week gave the life sciences industry pause.

Gottlieb has been an agile leader, who proved himself to be ready and willing to help the agency evolve as the health care sector becomes more technology-centric. It is reported that he issues more than 200 guidances a year, many aimed at easing the way for new technologies including digital therapeutics, gene therapies and wearable medical devices.

His two-year reign has been a particularly productive time for the industry with a record number of approvals for new molecular entities and biologics as well as generics and biosimilars.

While his departure will leave a void and the pace of change at the agency – much of which was driven by the 21stCentury Cures Act – may slow, it will not come to a standstill. There are still important initiatives underway including reform of the 510(k) process.

In late November, the FDA announced it is modernizing the 510(k) process – the pathway by which almost 82% of medical devices are cleared.

Under existing rules, which were established in 1976, devices can be cleared through the 510(k) pathway if the manufacturer can demonstrate that a new device is as safe and effective as an existing marketed device, termed a predicate device.

Gottlieb and the Center for Devices and Radiological Health Director (CDRH) Jeff Shuren, M.D. said in a statement issued in November that the changes are designed to encourage device manufacturers to rely on newer predicates – those less than ten years old – to ensure the latest technologies make their way to the clinic.

To encourage that end, the agency proposed publishing information on devices cleared based on a predicate that is older than ten years. It also may sunset certain older predicates that it believes are stifling innovation.

At the time of the November announcement, Gottlieb said in early 2019, the agency would finalize guidance on an alternative 510(k) pathway that “allows manufacturers of well-understood device types to rely on objective safety and performance criteria to demonstrate substantial equivalence…”

So far, there hasn’t been any guidance on this alternative 510(k) pathway, but with Shuren remaining at the helm of CDRH, we should expect the 510(k) modernization process will proceed forward in the months ahead.

 

 

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