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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 the Submission of Premarket Notifications for Photon-Emitting Brachytherapy Sources - Guidance for Industry  Food and Drug Administration (FDA) Final
Guidance for the Submission of Premarket Notifications For Radionuclide Dose Calibrators - Guidance for Industry  Food and Drug Administration (FDA) Final
Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials (PDF Version)  Food and Drug Administration (FDA) Final
Guidance on 510(k) Submissions for Keratoprostheses - Guidance for Industry and for FDA Reviewers/Staff  Food and Drug Administration (FDA) Final
Guidance on Labeling of Foods That Need Refrigeration by Consumers  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
Guidance on Premarket Notification [510(k)] Submissions for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care Facilities  Food and Drug Administration (FDA) Final
Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes  Food and Drug Administration (FDA) Final
Guidance on Section 216 of the Food and Drug Administration Modernization Act of 1997 - Guidance for Industry and for FDA Reviewers  Food and Drug Administration (FDA) Final
Guidance on the Content and Format of Premarket Notification [510(k)] Submissions for Sharps Containers  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.