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GUIDANCE DOCUMENT

Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices Guidance for Industry and Food and Drug Administration Staff October 2023

Download the Final Guidance Document
Final
Docket Number:
FDA-2015-D-2148
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This guidance document provides the FDA's recommendations on the information to support premarket submissions for a magnetic resonance diagnostic device (MRDD). The recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of MRDD submissions.

Submit Comments

Submit Comments Online

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.

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