As of July 1, like every year, it is possible to submit the Annual Report to the Center for Devices and Radiological Health (CDRH)

Annual report shall be submitted as of July 1 until September 1, 2017. It involves radiation-emitting device manufacturers who already submitted A Product Report and regardless of reporting further changes through a Supplemental Report.

The reports shall contain relevant data such as instructions relating to devices manufactured, sold and installed in the territory between July 1, 2016 and June 30, 2017. Once the CDRH received the Annual Report, it will provide an Accession Number, a unique identifier to be communicated to the importer in the US in order to regularly market radiation-emitting devices.


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