On November 21, 2024, the FDA’s Center for Devices and Radiological Health (CDRH) announced a pilot communications program for improving the timeliness for communicating high-risk recalls.[1] The CDRH intends for the pilot program to provide early alerts of high-risk device removal or corrections related to a subset of device categories within the CDRH’s purview, including cardiovascular, gastrorenal, general hospital, obstetrics and gynecology, and urology devices.[2] No changes are being made to other recall processes.
The new pilot program is part of a broader effort to modernize communication around recalls. The FDA held a public meeting in the fall of 2023, followed by a comment period, regarding recalls and related communications for a wide variety of FDA-regulated products.[3] Additionally, the CDRH’s 2024 Annual Report stated its intent to strengthen the medical device recall program, specifically committing to providing “timely and informative recall information.”[4]
The CDRH maintains an email list for purposes of providing alerts regarding medical device safety and recalls.[5]
This news comes in the same week as the President-elect announced Dr. Martin Makary as his pick for FDA Commissioner.[6] If confirmed by the Senate, Dr. Makary would take over from Dr. Robert Califf, who has served as FDA Commissioner since February 2022, previously having served as FDA Commissioner from February 2016 to January 2017.
Editor: Brenden S. Gingrich, Ph.D.
[1] See CDRH Announces Communications Pilot to Enhance Medical Device Recall Program, FDA.gov (visited November 25, 2024) (https://www.fda.gov/medical-devices/medical-devices-news-and-events/cdrh-announces-communications-pilot-enhance-medical-device-recall-program).
[2] Id. See also Center for Devices and Radiological Health, FDA.gov (visited November 25, 2024) (https://www.fda.gov/about-fda/fda-organization/center-devices-and-radiological-health).
[3] Public Meeting: Modernizing Recalls of FDA-Regulated Commodities, FDA.gov (visited November 25, 2024) (https://www.fda.gov/about-fda/regulatory-news-stories-and-features/public-meeting-modernizing-recalls-fda-regulated-commodities-09292023).
[4] 2024 CDRH Safety Report, FDA.gov (visited November 25, 2024) (https://www.fda.gov/media/177866/download?attachment).
[5] Subscribe to CDRH Email Lists, FDA.gov (visited November 25, 2024) (https://www.fda.gov/about-fda/center-devices-and-radiological-health/subscribe-cdrh-email-lists).
[6] Berkeley Lovelace Jr., Trump Picks Dr. Marty Makary, a Johns Hopkins surgeon, for FDA chief, NBC News (visited November 25, 2024) (https://www.nbcnews.com/health/health-news/trump-picks-dr-marty-makary-johns-hopkins-surgeon-fda-chief-rcna180883); Jonathan Gardner and Ned Pagliarulo, Johns Hopkins surgeon Makary is Trump’s pick to lead FDA, BioPharmaDive, (visited November 25, 2024) (https://www.biopharmadive.com/news/trump-fda-martin-makary-surgeon-nominate/733498/).
Subscribe for News and Updates
