Safety and Performance Based Pathway Device-Specific Guidances; Draft Guidances for Industry and Food and Drug Administration Staff; Availability
Primary source
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Issuing agencies
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of two draft device-specific guidance documents for the Safety and Performance Based Pathway--specifically, ``Denture Base Resins--Performance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff'' and ``Facet Screw Systems--Performance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff.'' The device-specific guidances identified in this notice were developed in accordance with the finalized guidance entitled ``Safety and Performance Based Pathway.'' These draft guidance documents are not final nor are they in effect at this time.
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