미국 FDA

[FDA] Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices

MD우야 2023. 10. 16. 09:00
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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 intended to be used in conjunction with information regarding the content and format of a 510(k) premarket notification. The approach outlined in this guidance document is intended to facilitate the timely review and marketing clearance of MRDDs.

 

 

 

 

Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices | FDA

 

Premarket Notifications for Magnetic Resonance Diagnostic Devices

This guidance document provides a description of the information to be included in a premarket notification for a magnetic resonance diagnostic device.

www.fda.gov

 

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