FDA Watch: Latest Plan to Simplify 510(k) Premarket Review of New Tests

While everybody agrees that the FDA 510(k) premarket review pathway is antiquated and in desperate need of an overhaul. For several years, the FDA, Congress and lab industry have been working together on a solution. Now, after all the fits, starts and false hopes, real relief may actually be on the way. Here’s a quick recap of the FDA’s newly proposed plan.

The 510(k) Pathway
Device and diagnostic test manufacturers can use the 510(k) pathway to secure expedited approval for new products that they can show are substantially equivalent to products that were grandfathered in when Congress created the pathway back in 1976. The absurdity of using technology that’s 40+-years-old as the standard for letting new products into the market is lost on nobody. 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 FDA Proposal
Of course, 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. Its November 2018 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, i.e., publication of manufacturers and products who rely 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 NIR, Sept. 2018) is passed. That’s because 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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