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MEMORANDUM

Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (Part 2) March 1989

Final

Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (Part 2)

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

This letter states the Food and Drug Administration's (FDA) position regarding certain questions which arose after performance standards for CT systems were published. This letter supersedes the March 25, 1985, letter on the same subject.


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:

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.