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HHS Guidance Submissions

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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
FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
General Wellness: Policy for Low Risk Devices: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
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