Today, the FDA’s Center for Devices and Radiological Health (CDRH) is announcing a pilot 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 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.
Since 2009, CDRH has taken significant steps to further strengthen our medical device recall program and assure safe and effective medical devices. This includes issuing numerous guidance documents to provide recommendations to medical device manufacturers to ensure their devices are safe and effective and comply with applicable laws and regulations. We continue to engage with industry to better understand where the Center can provide additional clarity on recommendations and requirements. We also engage with patients and health care providers to ensure they have the information they need when devices are recalled.
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, we held a public meeting on September 29, 2023, for interested parties to share information and feedback about topics related to recall modernization and communication. We also committed to several actions in 2024 to help advance medical device safety, including to further reduce the time of public notification once the FDA becomes aware of a recall and continue to enhance communications to the public about recalls, as noted in our 2024 Safety Report.
Today, I reaffirm our commitment to proactively addressing safety concerns, managing recalls effectively, and building on the foundation laid by my predecessor, Dr. Jeff Shuren, whose initiatives paved the way for the development of systems that enhance our detection, monitoring, and remediation of device safety issues and advance patient safety.
The FDA takes seriously our role in communicating both the benefits and risks of medical devices to support an informed public and strong health care system. We will continue working to assure the U.S. is among the first to detect and address safety signals, working closely with our domestic and international partners, to help ensure patients, consumers, and health care providers can depend on the devices CDRH approves, clears, and authorizes for marketing. We will continue maximizing every available approach and resource within our legal authorities to take prompt action and communicate our actions publicly, when appropriate to achieve optimal public health outcomes.
