Skip to main content
U.S. flag

An official website of the United States government

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.

Filter Guidance Documents by ...

HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date
Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Radioactive Drug Research Committee: Human Research Without An Investigational New Drug Application  Food and Drug Administration (FDA) Final
Rare Diseases: Considerations for the Development of Drugs and Biological Products  Food and Drug Administration (FDA) Final
Real-World Data: Assessing Registries To Support Regulatory Decision-Making for Drug and Biological Products  Food and Drug Administration (FDA) Final
Recommendations for the Management of Donor and Units that are Initially Reactive for Hepatitis B Surface Antigen (HBsAg)  Food and Drug Administration (FDA) Final
Recommendations for the Quarantine and Disposition of Units from Prior Collections from Donors with Repeatedly Reactive Screening Tests for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) and Human T-Lymphotropic Virus Type I (HTLV-I)  Food and Drug Administration (FDA) Final
Recommendations Regarding License Amendments and Procedures for Gamma Irradiation of Blood Products  Food and Drug Administration (FDA) Final
Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities  Food and Drug Administration (FDA) Final
Recommended Approaches to Integration of Genetic Toxicology Study Results  Food and Drug Administration (FDA) Final
Recommended Clinical Study Design for Ventricular Tachycardia Ablation  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.