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

News | RSNA

July 15, 2026 — The Radiological Society of North America has announced its lineup of plenary speaker for RSNA 2026 ...

Time July 21, 2026
arrow
News | Radiology Imaging

July 20, 2026 — Bracco Imaging has earned the 2026 EcoVadis Platinum Medal, the highest level of recognition awarded by ...

Time July 21, 2026
arrow
News | ACR

July 15, 2026 — The American College of Radiology (ACR) recently issued a statement praising the inclusion of the ...

Time July 16, 2026
arrow
News | Ultrasound Imaging

July 13, 2026 — Neal F. Kassell, MD, founder and chairman of the Focused Ultrasound Foundation, received the inaugural ...

Time July 13, 2026
arrow
News | Radiation Oncology

July 10, 2026 — A new study led by researchers at the Icahn School of Medicine at Mount Sinai found that although the ...

Time July 10, 2026
arrow
News | Magnetic Resonance Imaging (MRI)

July 7, 2026 — Imagion Biosystems, Ltd. recently announced it has renewed and extended its collaboration agreement with ...

Time July 07, 2026
arrow
News | MRI Breast

July 2, 2026 – Quibim has announced the European and UK launch of QP-Breast, its CE and UKCA-marked AI tool which ...

Time July 02, 2026
arrow
News | Interventional Radiology

June 25, 2026 — Radiologists performing no interventional radiology-related (IR-related) work increased from one-third ...

Time June 25, 2026
arrow
News | Mammography

June 23, 2026 — Using artificial intelligence (AI), researchers found that image-based risk scores for breast cancer ...

Time June 24, 2026
arrow
Feature | X-Ray | Kyle Hardner

Water-window X-rays allow researchers to visualize biological cells at high contrast without staining agents or other ...

Time June 23, 2026
arrow
Subscribe Now