Feb 6, 2018


  • US FDA has updated its 510(k) Refuse to Accept and Premarket Approval acceptance policies for combination product submissions.
  • The updated guidances include new requirements for drug patent and exclusivity information.

FDA 510(k) Refuse to Accept and PMA acceptance policy changes for combination productsTo clarify regulatory requirements for combination drug/medical device products, the US Food and Drug Administration has published updated guidances on their Premarket Approval (PMA) acceptance process and Refuse to Accept policy for initial reviews of 510(k) submissions.

The updated PMA and 510(k) Refuse to Accept guidances replace final versions published in 2012 and 2015, respectively. FDA PMA and 510(k) registrants whose devices are classified as combination products have 60 days to incorporate changes included in these guidances into their compliance processes, or be prepared to provide data pertaining to drug components of their devices to the regulator upon request during submission reviews if they cannot meet the 60-day deadline.

FDA’s changes to these guidances stem from provisions in the 21st Century Cures Act of 2016 covering regulation of combination products.

New combination product information requirements

Both the 510(k) Refuse to Accept and PMA acceptance and filing review updated guidance documents include new disclosure requirements for registrants whose combination products include drug components.

Specifically, registrants should include drug patent information as well as any exclusive marketing rights that may cover a combination product’s drug component. FDA reviewers will require this information as a factor in determining whether 510(k) and PMA applications are complete and can proceed to more in-depth reviews.

Related US FDA regulatory resources from Emergo:

  • US FDA consulting for medical device and IVD manufacturers
  • FDA 510(k) consulting for medical device and IVD registrants
  • Whitepaper: Preparing a US FDA 510(k) submission
  • In-depth Video: US FDA medical device registration and compliance


  • Stewart Eisenhart