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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Sort descending Guidance Status Issue Date
Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Enforcement Policy for Telethermographic Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
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