The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has proposed that devices that aim to eliminate disparities in health care be designated breakthrough products. The agency is also considering expanding its criteria for breakthrough devices to include products that treat rare diseases, as well as non-addictive products to treat pain or addiction.
These updates were proposed in a recent draft guidance issued on Thursday. If adopted, the measures would be incorporated in FDA’s final guidance on breakthrough devices issued in December 2018. (RELATED: FDA Finalizes Breakthrough Device Guidance, Outlines Safer Technologies Program, Regulatory Focus 18 December 2018).
The breakthrough device program, formerly known as the Expedited Access Pathway, was created by the 21st Century Cures Act…
