U.S. flag An official website of the United States government
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. A Guide For The Submission of an Abbreviated Report on X-ray Tables, Cradles, Film Changers or Cassette Holders Intended for Diagnostic Use
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

A Guide For The Submission of an Abbreviated Report on X-ray Tables, Cradles, Film Changers or Cassette Holders Intended for Diagnostic Use March 1996

Final
Docket Number:
FDA-2020-D-0957
Issued by:
Guidance Issuing Office
Office 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).


Submit Comments

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:

Dockets Management
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.