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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
FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Feasibility and Early Feasibility Clinical Studies for Certain Medical Devices Intended to Therapeutically Improve Glycemic Control in Patients with Type 2 Diabetes Mellitus: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
General Considerations for Animal Studies Intended to Evaluate Medical Devices: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
General Wellness: Policy for Low Risk Devices: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Global Unique Device Identification Database (GUDID): Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.