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GUIDANCE DOCUMENT

Guidance for the Submission of Cabinet X-Ray System Reports Pursuant to 21-CFR 1020.40 February 1975

Final
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

The Office of Compliance, Center for Devices and Radiological Health (CDRH) developed this guide. This guide will assist manufacturers of electronic products which emit radiation in providing adequate reporting of radiation safety testing and compliance with federal performance standards. Title 21 of the Code of Federal Regulations (CFR), Parts 1002 and 1003 specify Reporting and Notification requirements.


Submit Comments

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:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.