To market Medical Devices that emit certain types of radiation in the U.S. (see 21 CFR 1002.1 for details), a Product (Initial) Report must be submitted to CDRH. CDRH sends the manufacturer an Acknowledgement Letter containing the Accession Number, a unique identifier of the submitted Report.
This access number allows customs authorities (FDA import personnel) to confirm that the manufacturer has complied with at least the requirements of 21 CFR 1002.10 Product Reports for the product being imported. Without this number, the transit of the product will be blocked.
In the event of a change in the release dose or a change in the product safety test reports, a Supplemental Report containing the changed information must be submitted to CDRH.
Annually (by 1 September), notification must also be maintained by sending an Annual Report to CDRH indicating, among other things, the units placed on the U.S. market during the reporting period.