CBP Reminds Medical Device Importers of Upcoming Requirements After COVID Emergency Expired
CBP reminded medical device importers of upcoming changes to FDA medical device authorization and import requirements following the recent expiration of the U.S. COVID-19 public health emergency on May 11, in a CSMS message issued the following day.
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Citing guidance documents on medical devices with ending emergency use authorizations (EUAs) and enforcement discretion policies that are now set to end, the CBP guidance outlines requirements for importers of such medical devices, including what intended use and affirmation of compliance codes to use during the upcoming phases of the transition.
For EUAs associated with COVID, FDA intends to publish notice of when each EUA will be terminated, giving device companies 180 days to transition and file marketing submissions with the agency. Importers should continue to use intended use code 940.000 for EUAs during the transition period. Once the EUA is terminated, intended use code 081.001 for standard device imports should be transmitted, along with the appropriate FDA product code.
On the other hand, enforcement discretion policies listed in the FDA guidance will end 180 days after the end of the public health emergency on Nov. 7. Beginning May 11, manufacturers must follow adverse event reporting requirements, and beginning with phase 2 of the transition on Aug. 9, manufacturers must report corrections and removals.
Beginning with phase 3 on Nov. 7, “FDA expects any marketing submission for a device within the scope of the transition plan guidance to be submitted and accepted if the manufacturer intends to continue distribution of the device,” CBP said. “FDA does not intend to object to continued distribution of devices within the scope of the enforcement policy transition plan guidance where a marketing submission has been submitted and accepted by FDA before the start of Phase 3 and FDA has not taken a final action on the marketing submission,” CBP said.
During phases 1 and 2, filers should transmit intended use code 081.006 for enforcement discretion per final guidance, CBP said. Starting with phase 3, filers should transmit intended use code 081.001 for standard import of a device, it said.