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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
Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software: Guidance for Industry  Food and Drug Administration (FDA) Final
Data Integrity and Compliance With Drug CGMP: Questions and Answers: Guidance for Industry  Food and Drug Administration (FDA) Final
Data Standards for Drug and Biological Product Submissions Containing Real-World Data: Guidance for Industry  Food and Drug Administration (FDA) Final
Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions (Revised): Guidance for Industry  Food and Drug Administration (FDA) Final
Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products: Guidance for Industry  Food and Drug Administration (FDA) Final
Design Control Guidance For Medical Device Manufacturers: Guidance for Industry  Food and Drug Administration (FDA) Final
Determining Donor Eligibility for Autologous Donors of Blood and Blood Components Intended Solely for Autologous Use - Compliance Policy: Guidance for Industry  Food and Drug Administration (FDA) Final
Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products: Guidance for Industry  Food and Drug Administration (FDA) Final
E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential--Questions and Answers : Guidance for Industry  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.