Aug 11, 2022

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.

Cardiovascular devices show the most breakthrough device designations

In terms of which device clinical panels have received breakthrough designations through mid-2022, cardiovascular panels lead the pack with 163 designations, followed by neurology panels with 126 designations. Other clinical panel areas where devices have received sizeable FDA breakthrough designations include orthopedic, gastroenterology and urology, general and plastic surgery, immunology and anesthesiology.

FDA Breakthrough Devices Program eligibility

Per FDA’s guidance on the Breakthrough Devices Program, medical devices and combination products subject to FDA 510(k) premarket notification, premarket approval (PMA) or De Novo designation may qualify for breakthrough designation, provided they meet the following criteria:

  • The device facilitates more effective treatment or diagnosis of a life-threatening or debilitating disease or condition, and:
  • The device either represents a breakthrough technology; does not have any FDA-approved or cleared alternatives on the US market; offers significant advantages over existing options on the US market; or serves the best interest of patients.

Additional US FDA medical device regulatory resources from Emergo by UL:

  • FDA 510(k) consulting for medical device and IVD manufacturers
  • US FDA medical device classification support
  • FDA Pre-Sub (Q-Sub) consulting for medical device companies




  • Stewart Eisenhart