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Guidance Issuing OfficeCenter for Devices and Radiological Health
This guidance document provides a detailed description of the information that should be included in a premarket notification for a magnetic resonance diagnostic device (MRDD). This document is a recommendation of how to comply with certain requirements contained in 21 CFR 807.87 and is intended to be used in conjunction with information regarding the content and format of a 510(k) premarket notification. For more information about the content and format of a 510(k), see FDA’s guidance entitled “Format for Traditional and Abbreviated 510(k)s” and FDA’s guidance entitled, “Refuse to Accept Policy for 510(k)s." The approach outlined in this guidance document is intended to facilitate the timely review and marketing clearance of MRDDs.
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-2015-D-2148.