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FDA extends pandemic-era policy allowing certain device, production changes without prior approval

November 2, 2023

The guidance, first issued in May 2020, was supposed to expire at the end of the public health emergency. The policy allowed for any required production process changes, like social distancing, or manufacturing changes due to supply chain shortages, which were severe in some cases early in the pandemic.

The FDA extended the expiration date to 180 days after the PHE expired, which would be Nov. 7, but it has now extended the policy indefinitely due to ongoing challenges.

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