FDA Radiological Health Program: Updates on Reporting Forms, Annual Reports

CDRH has received approval from the Office of Management and Budget to extend all Radiation Safety reporting forms an additional 3 years until July 31, 2020.  CDRH will be updating the expiration dates on all the forms, but until that it finished, please continue to use the reporting forms found here: https://www.fda.gov/AboutFDA/ReportsManualsForms/Forms/RadiologicalHealthForms/default.htm .  Please note, this includes all Annual report forms, which are due by September 1, 2017.  If your company is a manufacturer of radiation-emitting electronic products, please check Table 1 in 21 CFR 1002.1 to determine whether your product area is subject to Annual reporting, see: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=1002.1 .

See FDA Radiation-Emitting Products homepage with OMB notice under Spotlight: https://www.fda.gov/Radiation-EmittingProducts/default.htm .

If you have questions in this regard, please contact DICE@fda.hhs.gov.