federal_register: 2010-29794

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2010-29794 Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Clostridium difficile; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled "Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Clostridium difficile." This draft guidance document describes FDA's recommendations concerning 510(k) submissions for various types of in vitro diagnostic devices (IVDs) intended to be used for detecting Clostridium difficile (C. difficile). This draft guidance is not final nor is it in effect at this time. 2010-11-29 2010 11 https://www.federalregister.gov/documents/2010/11/29/2010-29794/draft-guidance-for-industry-and-food-and-drug-administration-staff-establishing-the-performance https://www.govinfo.gov/content/pkg/FR-2010-11-29/pdf/2010-29794.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled "Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Clostridium difficile." This draft guidance...

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