Comedown From Height of COVID Marks Shift for FDA Medtech Approval Strategy

The FDA is signaling a general slowdown of approvals for medtech innovations as the U.S. recovers from an interminable, not-officially-concluded COVID-19 pandemic as well as the global supply chain hold-ups that plagued nearly every major industry. The agency’s Device Center Director, Dr. Jeffrey Shuren, has said that the reduction in approvals matches the decline in product applications received. Speaking at AdvaMed’s recent MedTech Conference in Boston, he remarked, “We've heard from companies that things are just taking longer. We know industry has been hit hard with COVID — a lot of things got backlogged, like continuing data collection and getting submissions in the door. But we are monitoring this.”

The past decade has seen an over fourfold increase in novel device authorizations — from just under 30 in 2010 to a whopping 132 in 2020, a year in which applications where up 60% from the prior year due to a large number of companies wanting in on the lucrative business of devising products for “combatting COVID.” This year, though more than 1,400 requests have poured in for Emergency Use Authorizations, the total volume of submissions through mid-October constitutes a 20% decrease from 2019. In the throes of the pandemic, the FDA assessed more than 8,000 EUA requests, granting approvals to more than 2,300 devices — 444 of which were diagnostic tests.

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Now, as the public health emergency wanes and COVID edges toward becoming an endemic, seasonal nuisance, the agency is shifting its focus to evaluating the full clearance needed for a variety of COVID test and products that heretofore hinged on EUAs, many of which are nearing their expiration dates.