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Guidance Documents/Guidance-Document/Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices - Guidance for Industry and Food and Drug Administration Staff

Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices - Guidance for Industry and Food and Drug Administration Staff

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

June 19, 2014

March 24, 2020

Center for Devices and Radiological Health

9d5e44dc-a38c-4817-93c0-e7786f404f88

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