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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Sort descending Guidance Status Issue Date
Emergency Use Authorization of Medical Products and Related Authorities: Guidance for Industry and Other Stakeholders  Food and Drug Administration (FDA) Final
Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers: Guidance for Industry and Review Staff  Food and Drug Administration (FDA) Final
Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications: Draft Guidance for Industry and Review Staff  Food and Drug Administration (FDA) Proposed
Enforcement Policy for Certain (Provisional) Tobacco Products that FDA Finds Not Substantially Equivalent: Guidance for Industry and Tobacco Retailers  Food and Drug Administration (FDA) Final
Content and Format of INDs for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-Derived Products. Questions and Answers: Guidance for Industry Q&A  Food and Drug Administration (FDA) Final
The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Design Considerations for Pivotal Clinical Investigations for Medical Devices: Guidance for Industry, Clinical Investigators, Institutional Review Boards and FDA Staff  Food and Drug Administration (FDA) Final
Enforcement Policy for Remote Digital Pathology Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry, Clinical Laboratories, Healthcare Facilities, Pathologists, and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
The Meaning of "Spouse" and "Family" in FDA's Regulations after the Supreme Court's Ruling in United States v. Windsor: Questions and Answers: Guidance for Industry, Consumers, and FDA Staff  Food and Drug Administration (FDA) Final
Manufacturer's Notification of the Intent to Use an Accredited Person under the Accredited Persons Inspection Program Authorized by Section 228 of the Food and Drug Administration Amendments Act of 2007 (FDAAA): Guidance for Industry, FDA Staff, and FDA  Food and Drug Administration (FDA) Final
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