Safety and Performance Based Pathway Device-Specific Guidances; Guidance for Industry and Food and Drug Administration Staff; Availability
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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.
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."
Abstract as published in the Federal Register.
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