A Guide For The Submission Of Abbreviated Initial Reports On Image Receptor Support Devices For Mammographic X-Ray Systems
This guide 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 on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.