The pilot aims to minimize the time between the FDA’s initial awareness of and public notification of potentially high-risk medical device removals or corrections.
Summary: The FDA’s Center for Devices and Radiological Health (CDRH) has announced a pilot program to improve the timeliness of public communications about potentially high-risk medical device recalls or corrections. The initiative focuses on providing early alerts for issues involving cardiovascular, gastrorenal, general hospital, obstetrics, gynecology, and urology devices. This effort builds on recommendations from the Patient Engagement Advisory Committee (PEAC) and aims to enhance transparency, address safety concerns more proactively, and better meet patients’ needs.
Key Takeaways:
- Faster Communication on High-Risk Devices: The pilot program aims to reduce the time between the FDA’s initial awareness of high-risk medical device recalls or corrections and public communication, providing timely alerts to health care providers and the public.
- Focus on Specific Medical Categories: The pilot targets high-risk recalls or corrections in cardiovascular, gastrorenal, general hospital, obstetrics, gynecology, and urology devices, with no changes to recall processes for other device categories.
- Commitment to Transparency and Patient Safety: The initiative stems from PEAC recommendations and builds on the FDA’s ongoing efforts to enhance medical device recall processes, improve communication clarity, and address safety concerns proactively.
The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) announced a pilot aimed at improving 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. According to the CDRH, 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.
CDRH’s Efforts to Strengthen Recall Programs
The agency says it has taken steps since 2009 to strengthen the medical device recall program. These steps include issuing guidance documents to provide recommendations to medical device manufacturers to ensure their devices are safe and effective and comply with applicable laws and regulations.
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“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,” says Michelle Tarver, MD, PhD, director of the CDRH, in a release.
Following an Oct 6, 2021, Patient Engagement Advisory Committee (PEAC) meeting and recommendations from PEAC members on how CDRH can further enhance the medical device recall program to better meet patients’ needs, the CDRH 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 safety messages to the public.
Incorporating Patient Input
“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, the agency held a public meeting on Sept 29, 2023, for interested parties to share information and feedback about topics related to recall modernization and communication. The agency also committed to actions this year aimed to help advance medical device safety, including further reducing the time of public notification once the FDA becomes aware of a recall and continuing to enhance communications to the public about recalls, as noted in the 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,” says Tarver in the release.
Tarver continues, “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 US 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.”
