Ready or Not, Here Comes Medical Device Cybersecurity Legislation

FDA has previously released guidance on medical device cybersecurity, but it never really had teeth – until now.

Late last year, President Joe Biden signed a $1.7 trillion omnibus appropriations bill into law, which included authorization for FDA to confirm that medical devices meet specific cybersecurity standards before hitting the market. The law also requires medical device manufacturers to maintain adequate post-market surveillance from a cybersecurity standpoint, and addresses both device hardware design as well as device software, according to a report published by PwC. The legislation goes into effect tomorrow.