- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Devices and Radiological Health
This is a clarification to the FDA position regarding Radiation Control Regulations for Diagnostic X-Ray Equipment.
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.