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