Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (Part 2) March 1989
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Guidance Issuing OfficeCenter 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.
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:
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.