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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
Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Nonalcoholic Steatohepatitis (NASH): Guidance for Industry Technical Specifications Document  Food and Drug Administration (FDA) Final
Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: Guidance…  Food and Drug Administration (FDA) Final
Biocompatibility Testing of Medical Devices - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration…  Food and Drug Administration (FDA) Final
The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program: Draft Guidance…  Food and Drug Administration (FDA) Proposed
Biocompatibility Testing of Medical Devices - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program : Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration…  Food and Drug Administration (FDA) Proposed
The Accreditation Scheme for Conformity Assessment (ASCA) Program: Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed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
Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program: Guidance for Industry, Clinical Laboratories, 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
This Guidance Portal contains 4741 documents.