FDA guidance to expedite import entry review for medical devices

On March 24, the US Food and Drug Administration (FDA) issued a guidance letter to importers of medical devices, electronic product components, parts and finished product into the US.

The recommendations are intended to expedite the import entry review process.  Generally, when a shipment of regulated medical devices enters a US port, US Customs passes any entry information received from the importer to FDA to ensure the products in the shipment meets FDA requirements.  If the data provided to FDA is accurate and complete, it is more likely that the shipment will be processed based on import screening and not held for further FDA entry review.  Otherwise, FDA will undertake a manual review of each line of your entry — which will delay the shipment’s release.

FDA recommends that the following information be submitted on the CBP entry paperwork:

  • consistent and accurate identifiers for firms
  • correct product codes for the product being imported
  • Affirmations of Compliance (AofC) codes along with their appropriate qualifier

With respect to the latter, FDA has developed new AofC codes and revised old AofC codes for use when completing customs entries for imported medical devices, which are outlined in an appendix to the March 24 letter.

Importers should ensure that their import personnel – brokers, filers, in-house compliance staff — are well versed with these requirements.

Finally, FDA indicated that it will issue a second letter pertaining to the import entry filing process for products subject to both the medical device and electronic product radiation regulations.

The March 24 letter is available here.

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