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HHS Guidance Portal

The Guidance Portal is a public website that shows current guidance documents from the U.S. Department of Health and Human Services (HHS) and its Divisions.

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date
Multiple Function Device Products: Policy and Considerations: Guidance for Industry and Food and Drug Administration  Food and Drug Administration (FDA) Final
Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration  Food and Drug Administration (FDA) Final
Acceptance and Filing Reviews for Premarket Approval Applications (PMAs): Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Acceptance of Clinical Data to Support Medical Device Applications and Submissions: Frequently Asked Questions: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Acceptance Review for De Novo Classification Requests: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Adaptive Designs for Medical Device Clinical Studies: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Administrative Procedures for CLIA Categorization: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Air Powered Dental Handpieces and Air Motors - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Annual Reports for Approved Premarket Approval Applications (PMA) : Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Antimicrobial Susceptibility Test (AST) System Devices – Updating Breakpoints in Device Labeling: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.