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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 Support Enforcement under the IV-D Program and Privacy Protections under the Health Insurance Portability and Accountability Act  Administration for Children and Families (ACF) Final
Developing Medical Imaging Drug and Biological Products Part 1: Conducting Safety Assessments  Food and Drug Administration (FDA) Final
Developing Medical Imaging Drug and Biological Products Part 2: Clinical Indications  Food and Drug Administration (FDA) Final
Developing Medical Imaging Drug and Biological Products Part 3: Design, Analysis, and Interpretation of Clinical Studies  Food and Drug Administration (FDA) Final
CPG Sec. 690.300 Canned Pet Food (Withdrawn 4/30/2019)  Food and Drug Administration (FDA) Final
M4: The CTD -- Quality Questions and Answers /Location Issues  Food and Drug Administration (FDA) Final
Notice of FY 2004 Final Targeted Assistance Formula Allocations  Administration for Children and Families (ACF) Final
Q1E Evaluation of Stability Data  Food and Drug Administration (FDA) Final
Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices: Guidance for Industry and FDA Staff  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
This Guidance Portal contains 4132 documents.