FDORA implements new FDA requirements for foreign drug and medical device companies

On December 29, 2022, President Biden signed the Consolidated Appropriations Act, 2023 into law, which contains the Food and Drug Omnibus Reform Act (FDORA). FDORA includes a number of significant changes to the federal Food, Drug and Cosmetic Act (FDCA).

With specific regard to foreign manufacturers and importers of drugs and medical devices, FDORA contains new requirements for registration, inspections and certifications. FDA-registered foreign drug and device companies should take note of these new provisions immediately and begin adjusting their operations to reduce the risk of business interruption.

• Additional registration requirements for foreign establishments importing products to the US
  
  Currently, only foreign establishments that import (or offer for import) drugs or devices directly into the US are required to register and list with FDA. See 21 U.S.C. 360, Registration of producers of drugs or devices. FDORA, however, amends 21 U.S.C. 360(i), Registration of foreign establishments to require foreign producers to register and list any drug or device that is ultimately imported (or offered for import) into the US, even if it is first sent to another foreign establishment.
  
  Thus, under the new law, every person who owns or operates any establishment within any foreign country engaged in the manufacture, preparation, propagation, compounding or processing (including repackaging, relabeling or otherwise changing the container or wrapper) of a drug or device that is imported or offered for import into the US must register and list regardless of whether the drug or device undergoes any of those activities at another establishment outside the US before being ultimately imported or offered for import.
  
  The new registration requirement is effective immediately and must be implemented within two years of the signing date of FDORA.

• Inspections of foreign facilities
  
  
  • Recognition of foreign government inspections
    
    Currently, FDA may enter into agreements with foreign governments and agencies to recognize post-approval risk-based inspections of FDA-registered foreign establishments. See 21 U.S.C. 384e. Pursuant to FDORA, however, FDA’s ability to enter into such agreement is extended to both pre-approval and post-approval inspections. 
    
    
  • Unannounced foreign drug facility inspections pilot program
    
    FDORA creates a new program to increase the number of unannounced foreign drug facility inspections. The program is to be initiatied within 180 days of the signing of FDORA and will result in a report detailing the number of unannounced inpections, the number of violations reported pursuant to announced versus unannounced inspections and any barriers encountered to unannounced inspections. The report will be made publicly available and posted to FDA’s website.
    

• Medical device certificates to foreign governments
  
  FDORA changes the requirements for obtaining a CFG stating that a device is in compliance with the requirements of the FDCA and can be legally marketed in the US. Previously, an FDA-registered foreign device manufacturer could receive a CFG upon a showing that the establishment had either been inspected by FDA or through a US audit program within three years of the request. Pursuant to FDORA, CFGs will only be issued upon a showing that a device is (i) listed, (ii) cleared (510(k)), approved (PMA) or exempt from premarket submissions, and (iii) imported or offered for import into the US.

Foreign manufacturers and importers of drugs and medical devices seeking advice on how to maintain FDA compliance with the new registration, inspection and certification requirements should contact the author for regulatory guidance.