Devices

CDRH New Pilot on High-Risk Recalls

CDRH says a new device recall pilot program will look to improving communication timeliness about corrective actions being taken by companies on high-risk recall issues. “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,” a Center notice says. “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 Center says the pilot will offer early alerts involving potentially high-risk device removals or corrections related to cardiovascular, gastrorenal, general hospital, obstetrics and gynecology, and urology products. Outside of the pilot, there is no other change to any other recall process or recall communication timelines for other areas, it adds.

“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,” the notice says.

It quotes CDRH director Michelle Tarver as saying: “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.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome