- Docket Number:
- Issued by:
Guidance Issuing OfficeOffice of Global Regulatory Operations and Policy, Office of Regulatory AffairsOffice of Medical Products and Tobacco, Center for Devices and Radiological Health
Questions have been raised as to whether an assembler of diagnostic X-ray systems must register as a device manufacturer.
Assemblers of diagnostic X-ray systems are subject to the assembler certification (reports of assembly) requirements in 21 CFR 1020.30(d) and the Federal Food, Drug, and Cosmetic Act, Chapter V, Subchapter C - Electronic Product Radiation Control.* Such assemblers are exempt from registration.
*Material between asterisks is new or revised*
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-2013-S-0610.