The Food and Drug Administration today released a plan to improve medical device safety. The plan calls for increased funding to develop an active surveillance capability for FDA’s National Evaluation System for health Technology (NEST) and conduct post-market studies to evaluate specific safety concerns. The agency also will explore ways to streamline post-market safety mitigations; spur innovation towards safer medical devices; advance device cybersecurity; and integrate its activities to promote safety across the product lifecycle. With respect to cybersecurity, the agency plans to update premarket guidance to better protect against risks such as ransomware campaigns and vulnerabilities that could enable a remote multi-patient attack. It also will consider requiring firms to build into a product’s design the ability to update and patch device security and provide a “software bill of materials” listing software embedded in a device, and developing a CyberMed Safety Analysis Board to serve as a resource to device makers and FDA. The agency is accepting comments on the plan at https://www.regulations.gov.

Related News Articles

Headline
The Cybersecurity and Infrastructure Security Agency, FBI, Department of Defense Cyber Crime Center and the National Security Agency June 30 released a fact…
Headline
AHA President and CEO Rick Pollack explains how hospitals have made meaningful progress in patient safety and delivering high-quality care, in a column…
Headline
The Centers for Medicare & Medicaid Services today announced it has identified a fraud scheme targeting Medicare providers and suppliers. CMS said scammers…
Headline
The Administration for Strategic Preparedness and Response June 25 announced it conducted an exercise transporting simulated patients with high-consequence…
Headline
Ochsner Health's Stephen Saenz, sepsis program manager, and Teresa Arrington, director of robust process improvement for quality and patient safety, reveal how…
Headline
Today is #HAVhope Friday, a national day of awareness highlighting how America’s hospitals and health systems combat violence in their workplaces and…