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