FDA Looks to Enhance Medical Device Recalls Through The New Program

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The FDA’s Center for Devices and Radiological Health (CDRH) has announced a pilot to reduce public notification of corrective actions taken by companies for devices that are high-risk recalls. These actions include a company’s removal of the product from the market, product corrections, or updates to product use instructions to minimize high safety risks.

According to CDRH, the pilot aims to be transparent and minimize the time between when the FDA first learns about certain corrective actions on products and when the public and healthcare providers are notified. Therefore, this will provide more timely communication to healthcare providers and the public.

The pilot is planned to provide early alerts of potentially high-risk device removals or corrections related to general hospital, cardiovascular, gastro-respiratory, obstetrics and gynecology, and urology. The center also noted that the recall process or recall communication timelines for other areas have not changed.

The FDA’s device recall process has been long criticized for being ineffective as being often tied to patient deaths and serious injuries. Calls for the FDA to speed up notices to patients and the public when there is a recall or other safety issues have been a consistent theme.

In recent years, product safety issues involving medical devices have put the FDA’s recall system in the public glare, such as health risks tied to Bayer’s Essure birth control device and cancer risks, deaths associated with breast implants, or Philips’ recall of more than 15 million respiratory products.

In the announcement, CDRH said to committed to minimizing the time between when the FDA and the public know about a recall after the Patient Engagement Advisory Committee (PEAC) meeting in 2021 and recommendations on how CDRH can further enhance their medical device recall program to better meet patients’ needs.

On the other hand, the announcement is still unclear exactly how these early alerts will be communicated. In addition, it is not clear how the FDA will have determined that a corrective action that a company has not proactively identified as a voluntary recall is indeed a recall and then reach a conclusion that it is likely to be the highest-risk class of recall (Class I).

Ashton Henning