For radiation-emitting devices, the manufacturers shall submit to CDRH (Center for Devices and Radiological Health) an Annual Report including information about the devices manufactured, sold and installed in the territory from July 1, 2015 until June 30, 2016. This submission must be executed between July 1, 2016 and September 1, 2016.
This is a consequence of the submission of an initial Product Report and independently from the reporting of changes listed in a Supplemental Report.
After the receipt of the report, the CDRH provides to assign a new Accession Number, to be communicated to the U.S. Importer in order to regularly place the radiation-emitting devices on the market.
For further information: