FDA Roundup: September 26, 2023

FDA News Release

• For Immediate Release: September 26, 2023

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 final guidance Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. This guidance provides recommendations on medical device cybersecurity considerations and what information to include in premarket submissions. The guidance replaces the FDA’s guidance Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, issued on October 2, 2014. The increased integration of wireless devices, electronic exchange of medical device-related information, and cybersecurity vulnerabilities and incidents, highlight the importance of having stronger cybersecurity measures. On November 2, 2023, the FDA will host a webinar for industry and other stakeholders interested in learning more about this guidance.
• Today, the FDA published the Treating Migraines: Ways to Fight the Pain with Medication Consumer Update. Thought there was no hope for treating your migraine headaches? Don’t give up. There are many FDA-approved medicines to reduce migraine pain and symptoms.
• On Monday, the FDA released draft Guidance for Industry (GFI) #273, to provide recommendations on how sponsors of approved medically important antimicrobial animal drugs used in medicated feed of food-producing animals may voluntarily establish a defined duration of use for indications that currently lack a defined duration of use. Revising antimicrobial drug labeling to better target when and for how long a drug may be used to treat, control, or prevent the disease(s) for which the product is indicated provides for the effective use of these products while minimizing the extent of antimicrobial drug exposure. Public comments on the draft guidance should be submitted by December 26, 2023 to ensure they are considered before FDA begins work on the final guidance.
• On Friday, the FDA and the Reagan-Udall Foundation for the FDA announced a public meeting on October 4 titled, “Mitigating Risks from Human Xylazine Exposure”. This public meeting will explore real-world experiences and scientific evidence on emerging data trends for human xylazine exposure and examine concrete strategies for drug development and clinical research that directly supports the mitigation and reduction of risks associated with human exposure to xylazine.