Today, the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) is announcing a communications pilot to enhance the medical device recall program.
This pilot is intended to improve the timeliness of communications about corrective actions being taken by companies that the FDA believes are likely to be the most serious type of recalls, but where the FDA may not yet have determined that the actions meet the regulatory definition of a recall. 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 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 consumers and health care providers. This pilot follows the commitments noted in our 2024 Safety Report and recommendations from the Patient Engagement Advisory Committee, to enhance our medical device recall program.
Specifically, the pilot will provide early alerts of potentially high-risk device removals or corrections removals or corrections related to:
- Cardiovascular,
- Gastrorenal,
- General hospital,
- Obstetrics and gynecology, and
- Urology
There is no change to any other recall process or recall communication timelines for other areas at this time.
This pilot demonstrates the important role of reflecting patient input in our regulatory efforts. 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.
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