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GUIDANCE DOCUMENT

Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices Guidance for Industry and Food and Drug Administration Staff November 2016

Final

This guidance is being distributed for comment purposes only.

Docket Number:
FDA-2015-D-2148
Issued by:
Guidance Issuing Office
Center 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.


Submit Comments

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:

Dockets Management
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.