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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
Class II and IIIA Laser Light Show Projectors and Shows (Laser Notice 40)  Food and Drug Administration (FDA) Final
Class II Special Controls Guidance Document: Immunomagnetic Circulating Cancer Cell Selection and Enumeration System (PDF version)  Food and Drug Administration (FDA) Final
Class II Special Controls Guidance Document: Serological Assays for the Detection of Beta-Glucan (PDF version)  Food and Drug Administration (FDA) Final
Clinical Data Presentations for Orthopedic Device Applications - Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Clinical Development and Labeling of Anti-Infective Drug Products  Food and Drug Administration (FDA) Final
Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA)  Food and Drug Administration (FDA) Final
Clinical Evaluation of Antiepileptic Drugs (adults and children)  Food and Drug Administration (FDA) Final
Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence - Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical Studies and Recommendations for Labeling  Food and Drug Administration (FDA) Final
Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.