FDA Unveils Medical Device Safety Plan
The Food and Drug Administration (FDA) this week announced a new plan to improve the government’s approach to medical device safety. The Medical Device Safety Action Plan outlines the FDA’s vision for device and patient safety.
According to a statement from FDA Commissioner Scott Gottlieb, MD, the FDA’s Center for Devices and Radiological Health (CDRH) has been working on new policies designed to “drive innovation in medical product development by taking novel approaches to regulation, including the use of real world evidence to support iterative improvements in device performance and establishing a balanced framework for digital health devices that improves the lives of patients.”
The action plan focuses on five areas:
- Establish a robust medical device patient safety net in the U.S.
- Explore regulatory options to streamline and modernize timely implementation of postmarket mitigations.
- Spur innovation toward safer medical devices.
- Advance medical device cybersecurity.
- Integrate CDRH’s premarket and postmarket offices and activities to advance the use of a total product life cycle approach to device safety.
As part of the medical device cybersecurity effort, the FDA is requesting funding from Congress to establish a CyberMed Safety (Expert) Analysis Board (CYMSAB). The CYMSAB would be a public-private partnership that would serve as a “go-team” to investigate a suspected or confirmed device compromise at a manufacturer’s or FDA’s request. It would also assess vulnerabilities, evaluate patient safety risks, adjudicate disputes, assess proposed mitigations, and consult with organizations navigating the coordinated disclosure process.
“Although medical devices provide great benefits to patients, they also present risks,” said Gottlieb in the statement. “And we are focusing equal attention on advancing new frameworks for identifying risks and protecting consumers.”