- Docket Number:
- Issued by:
Guidance Issuing OfficeOffice of Medical Products and Tobacco, Center for Devices and Radiological Health
This guide (FORM FDA 3661) presents an outline for a manufacturer to follow in preparing an abbreviated report, or abbreviated supplemental report, on x-ray tables, cradles, film changers or cassette
holders intended for diagnostic use. These certifiable components are subject to the Performance Standard, 21 CFR 1020.30, 1020.31, and 1020.32.
The focus of the guide is to identify the pertinent information required by the Food and Drug Administration for the specified certifiable components. Information submitted will be considered toward fulfillment of the requirements of the Radiation Control for Health and Safety Act of 1968 (Public Law 90-601).
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2020-D-0957.