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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
Chemical Analysis for Biocompatibility Assessment of Medical Devices: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Evaluation of Thermal Effects of Medical Devices that Produce Tissue Heating and/or Cooling: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Evidentiary Expectations for 510(k) Implant Devices: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Photobiomodulation (PBM) Devices - Premarket Notification [510(k)] Submissions: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Technical Considerations for Demonstrating Reliability of Emergency-Use Injectors Submitted under a BLA, NDA or ANDA: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Use of Investigational Tobacco Products: Draft Guidance for Industry and Investigators  Food and Drug Administration (FDA) Proposed
Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications: Draft Guidance for Industry and Review Staff  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4128 documents.