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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
Medical Devices and Clinical Trial Design for the Treatment or Improvement in the Appearance of Fungally-Infected Nails: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices): Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Medical X-Ray Imaging Devices Conformance with IEC Standards: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Metal Expandable Biliary Stents - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Mitigating the Risk of Cross-Contamination from Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Molecular Diagnostic Instruments with Combined Functions: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH): Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Nonbinding Feedback After Certain FDA Inspections of Device Establishments: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.