Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment Draft Guidance for Industry and Food and Drug Administration Staff December 2018
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Devices and Radiological Health, Office of Product Evaluation and Quality, Office of In Vitro Diagnostics and Radiological Health
This draft guidance provides clarification to industry and FDA staff of the Federal Regulations that relate to diagnostic x-ray systems and their major components. This draft guidance, when finalized, will supersede FDA’s guidance entitled “Clarification of Radiation Control Regulations for 19 Diagnostic X-Ray Equipment” (HHS Publication FDA 89-8221 issued in March 1989). For the current edition of the FDA-recognized standards referenced in this document, see the FDA Recognized Consensus Standards Database.
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.