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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
Sterilized Convenience Kits for Clinical and Surgical Use: Final Guidance for Industry  Food and Drug Administration (FDA) Final
Use of Nucleic Acid Tests on Pooled and Individual Samples From Donors of Whole Blood and Blood Components, Including Source Plasma, to Reduce the Risk of Transmission of Hepatitis B Virus: Final Guidance for Industry  Food and Drug Administration (FDA) Final
Labeling Recommendations for Single-Use Devices Reprocessed by Third Parties and Hospitals: Final Guidance for Industry and FDA  Food and Drug Administration (FDA) Final
Frequently-Asked-Questions about the Reprocessing and Reuse of Single-Use Devices by Third-Party and Hospital Reprocessors: Final Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Guidance on Medical Device Patient Labeling: Final Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Potency Tests for Cellular and Gene Therapy Products: Final Guidance for Industry:  Food and Drug Administration (FDA) Final
Financial Disclosure by Clinical Investigators: Guidance for Clinical Investigators, Industry,and FDA Staff  Food and Drug Administration (FDA) Final
Process for Handling Referrals to FDA Under 21 CFR 50.54 - Additional Safeguards for Children in Clinical Investigations: Guidance for Clinical Investigators, Institutional Review Boards and Sponsors  Food and Drug Administration (FDA) Final
Adverse Event Reporting to IRBs — Improving Human Subject Protection: Guidance for Clinical Investigators, Sponsors, and IRBs  Food and Drug Administration (FDA) Final
Investigational New Drug Applications (INDs) - Determining Whether Human Research Studies Can Be Conducted Without an IND: Guidance for Clinical Investigators, Sponsors, and IRBs  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.