Many see the FDA’s appointment of Kevin Fu as the first Director of Medical Device Cybersecurity as an indication that the agency will make medical device cybersecurity a priority this year, reports the National Law Review.
In this role, Fu reportedly hopes to bring together the various cross-functional subject matter experts involved in medical device development, and specifically to give software security experts a seat at the table, along with the medical and legal experts. Likely to be on his agenda include updates to the Agency’s guidance on the (i) content of premarket submissions for management of cybersecurity in medical devices, and (ii) content of premarket submissions for software contained in medical devices. Both guidance topics were identified as “A-list” priorities for 2021, along with a much-anticipated final guidance on clinical decision support software.
Read more in the National Law Review.