GAO Asked by Senators to Review FDA Handling of Medical Device Recalls

Senators Dick Durbin (D-Ill.) and Richard Blumenthal (D-Conn.) have asked the Government Accountability Office (GAO) to conduct a review of the FDA’s oversight of medical device recalls, citing a massive increase in adverse event reports and recall events in the past decade.

The letter notes that in FY 2022, “FDA oversaw 898 medical device recalls, impacting tens of millions of medical devices. This figure represents a 125 percent increase compared to FY 2012, when there were 399 medical device recalls.” Class I recalls totaled 70 in 2022, a 15-year high, the senators continue. “In FY 2012, FDA also received 486,986 adverse event reports, but it received 2,946,889 adverse event reports in FY 2022 – a 505 percent increase.”

Durbin and Blumenthal urged GAO to update its 2011 report “Medical Devices: FDA Should Enhance Its Oversight of Recalls” to ensure the FDA is adequately fulfilling its duty to ensure that medical device recalls are initiated in a timely manner. A list of 10 questions were included in the letter for GAO’s consideration in updating the report.

Read the letter here.

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