CDRH Announces Communications Pilot to Improve Medical Device Recall Program

According to a Nov. 21 press release, Michelle Tarver, M.D., Ph.D., director of the Center for Devices and Radiological Health (CDRH), released a statement on a communications pilot to improve the medical device recall program.

The FDA’s CDRH is working to “improve the timeliness of communications about corrective actions being taken by companies that the FDA believes are likely to be high-risk recalls. These actions may include when companies remove products from the market, correct products, or update instructions for using products due to potentially high safety risks. This pilot effort aims to increase transparency and minimize the time between the FDA’s initial awareness of and public communication of potentially high-risk medical device removals or corrections, providing more timely communication to health care providers and the public.”

The press release said, “The pilot will provide early alerts of potentially high-risk device removals or corrections related to cardiovascular, gastrorenal, general hospital, obstetrics and gynecology, and urology. At this time, there is no change to any other recall process or recall communication timelines for other areas.”

Further, “Following the October 6, 2021, Patient Engagement Advisory Committee (PEAC) meeting and recommendations from PEAC members on how CDRH can further enhance our medical device recall program to better meet patients’ needs, we committed to minimizing the time between the FDA’s awareness and public communication about certain potentially high-risk device issues and examining ways to more clearly communicate our safety messages to the public. Through PEAC, we work to assure the needs and experiences of patients are included as part of the FDA's deliberations on complex issues involving the regulation of medical devices and their use by patients. This pilot demonstrates the important role of incorporating patient input into our regulatory efforts.”

Additionally, CDRH held a public meeting on September 29, 2023, to share information and feedback about topics related to recall modernization and communication. CDRH also said it committed to several actions in 2024 to assist with advancing medical device safety, including further reducing the time of public notification once the FDA becomes aware of a recall and continue to enhance communications to the public about recalls.