What is the Product (Initial) Report to the CDRH?

In order to place a medical device that emits radiation on the US market it is necessary to submit a Product (Initial) Report to the CDRH so to obtain the Accession Number. It is recommended to submit the Report to the CDRH at least one month before the date set for its placement on the market to give the CDRH enough time to send the Manufacturer the Acknowledgment Letter containing the Accession Number or the identification number of the submitted Report.

The Accession Number must be communicated to the Importer on the territory in order to carry out the correct procedure for the placement on the US market. This access number will be checked by the customs authorities at the goods entrance and if it is missing the transit 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 US market during the reference timeframe.

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