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• Today, the FDA issued the draft guidance Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act. This draft guidance proposes updated recommendations to industry on quality system considerations for cyber devices and for documentation in device premarket submissions.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 guidance. 
• Today the FDA advised consumers in Some Medicines and Driving Don’t Mix to make sure they know if their prescription or over-the-counter medication can cause side effects that may make it unsafe to drive. Most medications won’t affect consumers’ ability to drive safely or operate other heavy machinery, but some do.
• On Monday, the FDA’s Center for Devices and Radiological Health Center Director, Dr. Jeff Shuren — serving as chair of the International Medical Device Regulators Forum (IMDRF)— welcomed attendees to the 25th Session of the International Forum. This was  the largest attendance in the history of IMDRF with nearly 1,200 people participating (in-person and virtually) from 62 countries. This forum was created in 2011 out of the Global Harmonization Task Force, with the goal of harmonizing the world’s approach to how we oversee medical devices.
• On Friday, the FDA issued a Safety Alert advising restaurants and retailers not to serve or sell and consumers not to eat certain mussels from Newfoundland, Canada due to potential contamination.

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