Like every year, between July 1 and September 1, 2019 manufacturers of radiation-emitting medical devices are required to submit the Annual Report to the CDRH (Center for Devices and Radiological Health).

USA: CDRH Annual Report 2019

All manufacturers who have already submitted a Product Report are responsible for submitting the Annual Report, regardless of any changes indicated by means of the Supplemental Report.

Every medical device manufacturer required to submit the Annual Report is bound to submit a report covering the production (the volume of products manufactured, sold or installed) for the United States, from July 1 of the previous year until June 30 of the current year.

Once the Report is received, the CDRH will reassign the Accession Number, a vital piece of information to be communicated to the local Importer, which will allow them to carry out the compliant marketing of radiation emitting devices in the United States.