The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) is initiating a pilot centred on improving the timeliness of communications to the public around corrective actions being taken by companies with devices believed to be high-risk recalls.
The pilot will provide early alerts on potentially high-risk device removals or corrections related to cardiovascular, gastrorenal, general hospital, obstetrics and gynaecology, and urology devices, the CDRH said. Subsequent actions may occur when companies remove products from the market, correct products, or update instructions for using products due to potentially high safety risks.
The CDRH added that no changes to any other recall process or recall communication timelines for other areas are planned at this time.
The commitments made to minimising the time between the FDA’s awareness and public communication about certain potentially high-risk device issues and examining ways to communicate its safety messages more clearly to the public, were borne out of a Patient Engagement Advisory Committee (PEAC) meeting in 2021 and a subsequent public meeting in September 2023, in which interested parties shared feedback about topics related to recall modernisation and communication.
This year, the FDA also committed to several other actions aimed at helping to advance medical device safety, including enhancements around manufacturing quality and strengthening post-market surveillance initiatives as outlined in the CDRH’s 2024 Safety Report.
CDRH director Michelle Tarver said: “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 authorises for marketing.”
The pilot will affect public communication efforts over medical devices like heart pumps. In August 2024, the FDA issued a Class I recall over Johnson & Johnson company Abiomed’s heart pumps after nine pumps from a failed inspection lot were shipped to customers.
Other notable recent recall notices from the agency, albeit outside the scope of the CDRH’s pilot, include Baxter’s Life2000 ventilator devices due to charging issues, and sensors in Abbott’s FreeStyle Libre 3 continuous glucose monitoring system (CGM).
According to GlobalData analysis, in light of President-elect Donald Trump’s appointment of Robert F Kennedy Jr (RFK Jr) as US Secretary of Health and Human Services (HHS), an overriding call from the incoming administration for reduced government spending is all but certain to hit the FDA budget, reducing payroll and leaving fewer staff to handle approvals, recalls, and reviews.
