FDA pilot program aims to expedite high-risk medical device recall communication

Editor's Note

The US Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) has initiated a pilot program to improve the speed of public notifications regarding high-risk medical device recalls. According to a November 21 announcement, this initiative aims to minimize the time between the FDA's awareness of safety concerns and the dissemination of information to healthcare providers and the public. The pilot program will focus on devices related to cardiovascular, gastrorenal, general hospital, obstetrics and gynecology, and urology.  

The effort aligns with recommendations from the October 2021 Patient Engagement Advisory Committee (PEAC), which emphasized the importance of timely, clear communication to better address patient needs during recalls.  Key components of the pilot include:

• Early alerts for potentially high-risk device issues, such as removals, corrections, or updated usage instructions.
• Enhanced collaboration with industry, healthcare providers, and patients to refine recall processes and communication strategies.
• Ongoing efforts to modernize recall practices, as discussed in a September 2023 public meeting.

According to FDA, this initiative builds on the CDRH's longstanding commitment to medical device safety, which has included issuing guidance documents and strengthening recall protocols since 2009.