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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
Medical Glove Guidance Manual: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Non-clinical Information for Femoral Stem Prostheses: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Pharmacogenetic Tests and Genetic Tests for Heritable Markers: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Postmarketing Safety Reporting for Combination Products: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Pre-Clinical and Clinical Studies for Neurothrombectomy Devices: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Premarket Assessment of Pediatric Medical Devices: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Preparation and Review of Investigational Device Exemption Applications (IDEs) for Total Artificial Discs: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Preparing Notices of Availability of Investigational Medical Devices and for Recruiting Study Subjects: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Principles of Premarket Pathways for Combination Products: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.