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Zdrowie i gospodarka · 14/08/2020

Safety and Performance Based Pathway Device-Specific Guidances; Guidances for Industry and Food and Drug Administration Staff; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of two final device-specific guidance documents for the Safety and Performance Based Pathway--specifically, "Cutaneous Electrode for Recording Purposes--Performance Criteria for Safety and Performance Based Pathway; Guidance for Industry and Food and Drug Administration Staff" and "Conventional Foley Catheters--Performance Criteria for Safety and Performance Based Pathway; 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."

Source: Federal Register — Food and Drug AdministrationOpen original release →