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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
Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI): Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Unique Device Identification System: Small Entity Compliance Guide: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Unique Device Identification: Convenience Kits : Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Unique Device Identification: Direct Marking of Devices : Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices: Guidance for Industry and Food and Drug…  Food and Drug Administration (FDA) Final
Unique Device Identifier System: Frequently Asked Questions, Vol. 1 : Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" : Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
User Fees and Refunds for De Novo Classification Requests : Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.