FDA medical device plan zeros in on cybersecurity, public-private partnership

siteadmin June 1, 2018

The FDA has released a five-point plan to improve medical device safety, which includes a reorganization of its medical device center and a proposed public-private partnership focused on cybersecurity. The plan also includes requirements for manufacturers to ensure devices are capable of being updated and receiving security patches, as well as potential regulations to expedite labeling changes and post-market updates. The FDA is also considering additional training for providers and a faster review process for devices with improved safety features.