October 28, 2022

FDA Proposes to Leverage Breakthrough Devices Program to Help Address Disparities

The U.S. Food and Drug Administration (FDA) released draft guidance, Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care, Oct. 21, for a 60-day public comment period. The document summarizes the FDA’s intended clarifications for the Breakthrough Devices Program.

The program provides medical device submissions meeting the criteria for the “breakthrough device” designation with additional FDA resources and internal prioritization to help successfully navigate the agency’s regulatory pathways to market. To date, several software as a medical device (SaMD) innovations have benefited from the program.

The FDA’s Oct. 21 draft guidance discusses the agency’s intention to consider technologies and device features expected to address healthcare disparities and promote health equity, and to include those considerations in their breakthrough device designation process. The draft also clarifies the timing of when the FDA will publicly disclose designations (i.e., following voluntary public disclosure by the manufacturer and/or when the device obtains marketing authorization for an indication consistent with its designation).

The American College of Radiology® (ACR®) is on record with federal legislators and regulators supporting prioritization for breakthrough device designation for any radiology AI SaMD innovations intended for use with pediatric patients. ACR is also on record supporting enhanced public transparency and engagement. For more information, please contact Mike Peters, ACR Senior Director of Government Affairs, Regulatory Policy.