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GUIDANCE DOCUMENT

Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (Part 1 ) March 1989

Download the Final Guidance Document
Final
Docket Number:
FDA-2018-D-4115
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This publication includes all current FDA Compliance Policy Guides pertaining to the Performance Standard, interpretations of the Performance Standard in either narrative or question-and-answer form, and interpretive letters that have been sent to the industry. Manufacturers are reminded that they must also meet pertinent requirements of the Medical Device Amendments, which are not addressed in this document.

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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-2018-D-4115.

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