House User Fee Bill Includes Medical Device Cybersecurity Requirements

House lawmakers included in their recently released draft user fee legislation a bipartisan measure to require medical device makers include cybersecurity in their device design and include information about device cybersecurity in their premarket submissions to FDA, heeding the agency’s recent request for Congress to give the agency new authorities to strengthen medical device cybersecurity. The Food and Drug Amendments of 2022, unveiled Wednesday (May 4), includes other medical device provisions, including a requirement that FDA’s medical device advisers meet...