FDA Begins Medical Device Safety and Innovation Overhaul

U.S. Food & Drug Administration (FDA) commissioner, Scott Gottlieb, MD, released a statement on April 17, 2018, outlining the agency’s efforts to “enhance and modernize” its approach to medical device safety and innovation. These efforts include a new medical device safety plan that will:

1. Establish a robust medical device patient safety net in the U.S.
2. Explore regulatory options to streamline and modernize timely implementation of postmarket mitigations
3. Spur innovation towards safer medical devices
4. Advance medical device cybersecurity
5. Integrate the Center for Devices and Radiological Health (CDRH)’s premarket and postmarket offices and activities to advance the use of a Total Product Life Cycle (TPLC) approach to device safety.

In addition, the FDA has issued a Draft Guidance on a voluntary, more modern 510(k) pathway for moderate risk devices to demonstrate safety and effectiveness. Comments on the new draft guidance can be submitted to the FDA at www.regulations.gov.

Read Dr. Gottlieb’s full statement.