News | Radiology Business | July 24, 2017

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 [email protected].

Related Content

Agfa Brings Intelligent Radiography to RSNA 2018
News | Digital Radiography (DR) | September 17, 2018
September 17, 2018 — At the 2018 Radiological Society of North America (RSNA) annual meeting, Nov.
SmartCurve technology, a revolutionary breast imaging technology designed specifically for the curvature of the female breast to provide every woman with a more comfortable and accurate mammogram.
News | Mammography | September 14, 2018
Solis Mammography declared September Breast Wellness Month a
At RSNA 2018, radiology professionals will discover intelligent radiography powered by MUSICA, at Agfa's booth.

At RSNA 2018, radiology professionals will discover intelligent radiography powered by MUSICA, at Agfa's booth.

News | Digital Radiography (DR) | September 13, 2018
At RSNA 2018, radiology professionals will discover intelligent
breast screening
News | Clinical Trials | September 13, 2018
Fewer and fewer women die from breast cancer in recent years but, surprisingly, the decline is just as large in the a
The DRX-Transportable System/Lite
News | X-Ray | September 12, 2018
Columbus Regional Health (Columbus, Ind.) has deployed a Carestream ...
Lightvision near-infrared fluorescence imaging system
News | Women's Health | September 11, 2018
Shimadzu Corp.
Feature | Breast Imaging | September 07, 2018 | By JoAnn Pushkin
If you are confused about the conflicting advice surrounding mammography screening guidelines, welcome to the club.
Feature | Radiology Business | September 07, 2018 | By Marilyn M. Singleton, M.D., J.D.
“Disruptive innovation” is all the buzz. Repealing the Affordable Care Act (ACA) is so last year. Well, disrupt this:...
Mount Sinai Serves as Official Medical Services Provider for 2018 U.S. Open
News | Orthopedic Imaging | September 06, 2018
For the sixth consecutive year, Mount Sinai will serve as the official medical services provider for the 2018 U.S. Open...