LDTs: FDA Announces New Approach to 510(k) Approvals

Last month, the FDA floated a plan to overhaul and modernize the 510(k) premarket review pathway allowing for faster, safer approval of medical devices, including diagnostics. Here’s a quick recap.

The 510(k) Pathway & the Need to Modernize
Device and diagnostics manufacturers can use the 510(k) pathway to get expedited approval for new products that they can show are substantially equivalent to products that were grandfathered in when Congress created the pathway in 1976. Translation: Technology that’s 40 or more years-old is being used as the standard for letting new products into the market.

There’s a perception that we’ve gone too far in stretching what’s “equivalent,” and that new 510(k) approvals should be compared to the benefits and risks of modern technology, notes Philadelphia attorney Janice Hogan who represents companies in the 510(k) process. 

The New Proposal
The FDA recognizes the problem and has taken steps to address it. In April 2018, the agency suggested that substantial equivalency of new products be evaluated based on objective performance criteria rather than predicate devices. The November guidance advances that objective via establishment of an alternative 510(k) pathway (to be called the “Safety and Performance Based Pathway”) that allows manufacturers of certain-well-understood device types to rely on objective safety and performance criteria to demonstrate substantial equivalence.

The proposal also calls for modernization via embarrassment via publication of manufacturers and products relying on predicate technology over 10-years-old.

Impact on the Lab Industry
Hogan suggests that the new rules will have less impact on diagnostics than therapeutics given the former’s current reliance on newer predicates. What’s more, adds Hogan, 510(k) may  become moot for diagnostics if some version of the Diagnostic Accuracy and Innovation Act (DAIA) (see National Intelligence Report, September, 2018) is passed. Explanation: DAIA would establish a new pathway for diagnostic tests instead of continuing to include them in the definition of a medical device within the scope of the 510(k) process.

Although it has bi-partisan support, Hogan cautions that DAIA is far from being a done deal. And unless and until it passes, new diagnostics will still have to go through the 510(k) process reach the market.


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