FDA Roundup: March 12, 2024

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued the draft guidance Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act. This draft guidance proposes updated recommendations to industry on quality system considerations for cyber devices and for documentation in device premarket submissions. Submit comments under docket number FDA-2021-D-1158 at www.regulations.gov by May 13, 2024, to ensure the FDA considers comments before it begins work on the final version of the guidance. On April 30, 2024, the FDA will host a webinar for those interested in learning more about the guid...