In order to place Medical Devices emitting certain types of radiation (see 21 CFR 1002.1 for details) on the US market, a Product (Initial) Report must be submitted to CDRH in order to obtain an Accession Number.

It is recommended that the Report be sent to CDRH at least one month prior to the date it is scheduled to be placed on the market to allow sufficient time for CDRH to send the Manufacturer the Acknowledgement Letter containing the Accession Number, i.e., the identification number of the submitted Report.

The Acknowledgement Number must then be communicated to the Importer in the territory in order to properly place the product on the market in the USA. This Accession Number will be checked by Customs at the entry of the goods and, in its absence, its transit 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.

In addition, notification must be made annually (by 1 September) by sending an Annual Report to CDRH indicating, among other things, the units placed on the US market during the reporting period.