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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
Responsibilities of Laser Light Show Projector Manufacturers, Dealers, and Distributors; (Laser Notice 51)  Food and Drug Administration (FDA) Final
Review Criteria For Premarket Approval of In Vitro Diagnostic Devices for Detection of Antibodies to Parvovirus B19  Food and Drug Administration (FDA) Final
Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA  Food and Drug Administration (FDA) Final
Review of FDA's Implementation of the Drug Export Amendments of 1986  Food and Drug Administration (FDA) Final
Reviewers Guidance Checklist For Orthopedic External Fixation Devices Version #5  Food and Drug Administration (FDA) Final
Revised Procedures for Adding Lens Finishing Laboratories to Approved Premarket Approval Applications for Class III Rigid Gas Permeable Contact Lenses for Extended Wear - Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Revised Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV)  Food and Drug Administration (FDA) Final
Revised Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV)  Food and Drug Administration (FDA) Final
Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry  Food and Drug Administration (FDA) Final
Role of HIV Drug Resistance Testing in Antiretroviral Drug Development  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.