FDA Announces Efforts to Modernize How It Issues Public Warnings about Voluntary Recalls

February 13, 2019 | Strategic Insights for Health System


​The U.S. Food and Drug Administration (FDA) announced on February 7, 2019, that it is strengthening and modernizing the ways it issues public warnings and notifications about voluntary recalls. The final guidance, published that day in the Federal Register, outlines the circumstance in which a company should issue a public warning about a voluntary recall, the general time frame to issue such a warning, and what type of information should be included, and it describes the actions that FDA might take if the warning is deemed insufficient. While it may seem like FDA is issuing more recalls, the press release said, in actuality 2018 represented a five-year low in recalls. However, FDA is increasingly publicizing recalls—already following its new guidance, the news release said.

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