federal_register: 2019-26470

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2019-26470 Magnetic Resonance Coil-Performance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Magnetic Resonance (MR) Coil--Performance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff." The device-specific guidance identified in this notice was developed in accordance with the final guidance entitled "Safety and Performance Based Pathway." This draft guidance is not final nor is it in effect at this time. 2019-12-09 2019 12 https://www.federalregister.gov/documents/2019/12/09/2019-26470/magnetic-resonance-coil-performance-criteria-for-safety-and-performance-based-pathway-draft-guidance https://www.govinfo.gov/content/pkg/FR-2019-12-09/pdf/2019-26470.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Magnetic Resonance (MR) Coil--Performance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug...

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