FDA Updates Data on Breakthrough Device Program

The U.S. Food and Drug Administration (FDA) reports that it has granted more than 650 medical devices designations under its Breakthrough Devices Program.

The Breakthrough Devices Program, which replaced the FDA’s earlier Expedited Access Pathway (EAP) program in 2019, is a voluntary program intended to provide patients and healthcare providers with more timely access to advance medical devices and device combination products. The Program offers device manufacturers a prioritized review of their submissions and direct access to FDA experts to address issues that develop during the premarket review phase.

To be eligible for designation under the Program, a device must meet two criteria, as follows:

  1. The device provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human diseases or conditions; and
  2. One of the following:
    1. Represents a breakthrough technology;
    2. No approved or cleared alternatives exist;
    3. Offers significant advantages over existing approved or cleared alternatives; or
    4. Device availability is in the best interest of the patient.

According to the latest data available, the FDA has granted 657 Breakthrough Device designations as of March 31, 2022. This includes 147 designations in 2020, 216 in 2021, and 64 for the year to date. Cardiovascular and neurological devices dominate the types of breakthrough designations so far, with 158 and 114 designations respectively.

More information about the FDA’s Breakthrough Device Program is available at the FDA’s website.

Read the FDA’s guidance on its Breakthrough Devices Program.

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