FDA Announces New Medical Device Safety Action Plan

April 25, 2018 — The U.S. Food and Drug Administration (FDA) released a new Medical Device Safety Action Plan outlining how the agency will encourage medical device innovation to improve safety, detect safety risks earlier, and keep doctors and patients better informed.  

“All medical devices have benefits and risks. And some of these risks are better understood once the device is more widely distributed and used under real-world conditions, in broader patient populations, and by a broader range of clinicians,” said FDA Commissioner Scott Gottlieb, M.D. “Our aim is to ensure not only that devices meet the gold standard for getting to market, but also that they continue to meet this standard as we get more data about devices and learn more about their benefit-risk profile in real world clinical settings.”

In the plan, subtitled “Protecting Patients, Promoting Public Health,” the FDA describes key actions it will take in the following areas:

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

The FDA welcomes comments and feedback on this proposal and encourages other ideas and suggestions on how it can strengthen its regulatory programs. Input may be submitted through the public docket (FDA-2018-N-1315) at www.regulations.gov.

For more information: www.fda.gov