FDA releases updated final guidance for its Breakthrough Devices Program

The FDA has released updated guidance for its Breakthrough Devices Program, which aims to ensure the safety and effectiveness of medical devices on the market and address healthcare disparities. The guidance defines “more effective” and explains the program’s availability for certain nonaddictive medical products. The FDA has granted marketing authorization to 77 of the 831 devices that received Breakthrough Device Designation. The guidance follows a draft aimed at reducing healthcare disparities, and the FDA has also highlighted its TAP Pilot program to facilitate earlier interactions between industry, the FDA, and stakeholders. A webinar will be held to discuss the guidance.