FDA device center’s 2022 report reveals 37% drop in annual breakthrough designations

Dive Brief:

  • The Food and Drug Administration reported a drop in use of its breakthrough device program;
  • Last year, the FDA’s Center for Devices and Radiological Health (CDRH) granted breakthrough status to 135 devices, down from the 213 designations awarded in 2021.  The number of devices with breakthrough status that received marketing authorization rose to 19 from 13; and
  • The FDA shared the data in CDRH’s annual report, which described the achievements made by the center in “another year of heavy workload and strained resources.”

Dive Insight:

The annual number of breakthrough designations climbed steadily in the early years of the program.  In its analysis of designations by financial year, which runs to 30 SEP 2023, the FDA reported a rise in the number of annual designations from 19 in 2017 to 206 in 2021.  However, the figure fell to 164 in the FDA’s 2022 financial year, and is lower still for the last calendar year.

Changes to the guidance on the breakthrough program could allow more devices to receive the status, with the FDA planning to update its advice to ensure the initiative is open to products that address health disparities, pain and addiction.  Other sections of the report describe the passage of Medical Device User Fee Amendments (MDUFA).  CDRH Director Dr. Jeff Shuren highlighted an advisory program pilot, a contentious part of the agreement that was initially opposed by industry, as an important part of the FDA’s plans to ensure timely access to new medical devices.  “A key component of MDUFA V is the Total Product Life Cycle Advisory Program Pilot, with the goal of improving medical device development by increasing the predictability and reducing the time from concept to commercialization – an approach that we very strongly believe will help improve patient access to safe and innovative medical devices first in the world,” Shuren said in a statement.

Shuren also highlighted the FDA’s work on pulse oximeters, the Philips recall of sleep and respiratory devices, cybersecurity and artificial intelligence (AI) among CDRH’s achievements in 2022.

REFERENCE:  MedTechDive; 31 JAN 2023; Nick Paul Taylor