Guidance on Where to Submit Cross-Center Master Files

FDA has issued a draft guidance, Cross-Center Master Files: Where to Submit, with recommendations for master file holders about to which Center a master file is to be submitted (1) that is referenced in and intended to support more than one regulatory submission for which the lead Center for those submissions may vary or (2) where the information in the Master File may need to be accessed and reviewed by more than one Center to support review of the referencing submission(s), such as combination product submissions. The document says that although the general master file concept is similar across the four medical product Centers (CBER, CDER, CDRH, and CVM), the recommendations for submitting master files and the master files hosted by each Center have aspects unique to that Center.

The recommended hosting Center for specific master files is based on the application and the files the master file is intended to support, the guidance says.