FDA’s breakthrough medical device designations tally nears 700

Stewart Eisenhart, Emergo Group

The US Food and Drug Administration has granted almost 700 designations over the past seven years under a voluntary program for expedited regulatory review of medical devices and combination products that facilitate more effective treatment or diagnosis of serious diseases.

According to recent metrics published by FDA, the agency has issued a total of 693 designations under its Breakthrough Devices Program, previously known as the Expedited Access Pathway (EAP). As of June 30, 2022, the bulk of these designations (687) have come through FDA’s Center for Devices and Radiological Health (CDRH), while the Center for Biologics Evaluation and Research (CBER) has granted another six such designations.

Although nearly 700 devices have been granted breakthrough designation, only 54 of these devices have obtained full US marketing authorizations.

Breakthrough designations gaining pace in recent years

FDA data shows that the …

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