To market a medical device that emits radiation (such as X-ray, laser, ultrasound, infrared, ultraviolet) in the U.S.A. it is necessary to send a Product (Initial) Report to the CDRH. This institution sends the Manufacturer an Acknowledgment Letter including the Accession Number, a single identifier of the Report previously submitted.
This Accession Number allows the customs authorities (FDA personnel handling imports) to confirm that the Manufacturer has complied at least with the 21 CFR 1002.10 Product Reports requirements for the product that is being imported. In the absence of such number, the transit of the product will be blocked.
In case of variation of the emission dose or changes to the product safety test reports, a Supplemental Report containing the modified information must be sent to the CDRH.
Furthermore, every year (by September 1) the notification must be maintained by sending an Annual Report to the CDRH indicating, among other things, the units placed on the U.S. market during the reference timeframe.
