ARTICLE SUMMARY:
FDA indefinitely extends COVID-era supply chain flexibilities. Excerpted from Pathways' Picks November 1: FDA Supply Chain Flex, AI Actions in the US and UK, and More.
The agency is adopting for the long term a COVID-19-era policy allowing device firms to switch out certain components or materials, or change manufacturing sites or procedures, without having to submit a PMA or HDE supplement to FDA. The goal is to allow companies to quickly respond to supply chain issues, potential shortages, or manufacturing limitations. “Following expiration of the [Public Health Emergency] declaration on May 11, 2023, FDA has continued to observe supply chain challenges and shortages of medical devices remain widespread,” the agency stated in a November 1 notice announcing the plan.
Under the extended policy, manufacturers can, for instance, replace circuit board components or other hardware that meets or exceeds original specifications if there is a supply interruption and FDA doesn’t need to sign off on the modification. Firms can also update non-tissue-contacting materials or make changes to production or packaging processes or locations to maintain manufacturing continuity or protect worker safety. Companies must validate and keep full records affirming the changes don’t negatively affect performance or safety.
The updated guidance that FDA issued November 1 on the policy is largely similar to the COVID-19-era guidance, albeit with expiration dates removed. One additional update in the new version is the agency now details specific factors that constitute an “established and acceptable history of GMP,” which must be in place for an alternative manufacturing site that is leveraged under the exemption policy.