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GUIDANCE DOCUMENT

Policy Clarification for Certain Fluoroscopic Equipment Requirements Guidance for Industry and Food and Drug Administration Staff May 2019

Final
Docket Number:
FDA-2014-D-1344
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This guidance document intends to clarify FDA’s interpretation of certain aspects of the performance standard requirements in 21 CFR 1020.30 and 1020.32 for fluoroscopic equipment.


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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:

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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2014-D-1344.