FDA Updates Radiological Reporting Forms, Annual Reports

X-ray performed on a GE Optima 646 DR system. The FDA has updated its radiology reporting forms on its website.

July 24, 2017 — The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has received approval from the Office of Management and Budget to extend all Radiation Safety reporting forms an additional three years until July 31, 2020. The CDRH will be updating the expiration dates on all the forms, but until that it finished, imaging centers are advised to continue to use the reporting forms found at www.fda.gov/AboutFDA/ReportsManualsForms/Forms/RadiologicalHealthForms/default.htm.

The CDRH said this includes all annual report forms, which are due by Sept. 1, 2017.

Manufacturers of radiation-emitting electronic products should check Table 1 in 21 CFR 1002.1 to determine whether its product area is subject to annual reporting, visit www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=1002.1.

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

For questions, contact the FDA at DICE@fda.hhs.gov.