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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
CPG Sec. 681.100 Order for Post-Approval Record Reviews (Withdrawn 2/20/2020)  Food and Drug Administration (FDA) Final
CPG Sec. 470.100 Orders for Post-Approval Record Reviews  Food and Drug Administration (FDA) Final
CPG Sec. 625.600 Orders for Post-Approval Record Reviews  Food and Drug Administration (FDA) Final
Preparation of Investigational New Drug Products (Human and Animal): Guidance for Industry  Food and Drug Administration (FDA) Final
Volume Limits for Automated Collection of Source Plasma  Food and Drug Administration (FDA) Final
Guidance on 45 CFR part 95, subpart F "Automatic Data Processing Equipment and Services--Conditions for Federal Financial Participation"--State Responsibilities.  Administration for Children and Families (ACF) Final
Guidance for the Content of Premarket Notifications for Ureteral Stents  Food and Drug Administration (FDA) Final
Guidance for the Content of Premarket Notifications for Biopsy Devices Used in Gastroenterology and Urology  Food and Drug Administration (FDA) Final
Guidance on the Content of Premarket Notification [510(K)] Submissions for Clinical Electronic Thermometers  Food and Drug Administration (FDA) Final
Guidance on Premarket Notification 510(k) for Sterilizers Intended for Use in Health Care Facilities  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4742 documents.