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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
Guidance for Industry and FDA Staff: Spinal System 510(k)s  Food and Drug Administration (FDA) Final
Guidance for Industry and FDA Staff: Vocal Fold Medialization Devices - Premarket Notification [510(k)] Submissions  Food and Drug Administration (FDA) Final
Guidance for Industry and FDA: Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/Processors with Interest in Exporting to Chile  Food and Drug Administration (FDA) Final
Guidance for Industry and Food and Drug Administration Staff - Assembler's Guide to Diagnostic X-Ray Equipment  Food and Drug Administration (FDA) Final
Guidance for Industry for the Submission of Chemistry, Manufacturing, and Controls Information for a Therapeutic Recombinant DNA-Derived Product or a Monoclonal Antibody Product for In Vivo Use  Food and Drug Administration (FDA) Final
Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements - Guidance for Industry and for FDA Reviewers/Staff  Food and Drug Administration (FDA) Final
Guidance for Industry | M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk  Food and Drug Administration (FDA) Final
Guidance for Industry: Frequently Asked Questions About GRAS for Substances Intended for Use in Human or Animal Food  Food and Drug Administration (FDA) Final
Guidance for Industry: Measures to Address the Risk for Contamination by Salmonella Species in Food Containing a Pistachio-Derived Product as an Ingredient  Food and Drug Administration (FDA) Final
Guidance for Industry: Preparation of Food Contact Substance Notifications (Administrative)  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.