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 volume of Breakthrough Device designations has increased significantly starting in 2018, when the agency revamped the program to replace its erstwhile EAP. Whereas only 11 Breakthrough Device designations were issued during the first year of the EAP (2015), 206 products achieved such designation in 2021; so far, FDA has issued 129 Breakthrough Device designations in 2022.
A combination of greater industry awareness regarding Breakthrough Devices Program qualification criteria and submission requirements as well as appropriate FDA resourcing may help explain steadily increasing designations from the regulator.
Get the full story at the Emergo Group’s blog.
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