Safety and Performance Based Pathway Device-Specific Guidances; Guidance 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 four final device-specific guidance documents for the Safety and Performance Based Pathway--specifically, "Air Powered Dental Handpieces and Air Motors--Performance Criteria for Safety and Performance Based Pathway," "Dental Ceramics--Performance Criteria for Safety and Performance Based Pathway," "Dental Impression Materials--Performance Criteria for Safety and Performance Based Pathway," and "Dental Cements--Performance Criteria for Safety and Performance Based Pathway." The device-specific guidances identified in this notice were developed in accordance with the finalized guidance entitled "Safety and Performance Based Pathway."
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