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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 Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
The Abbreviated 510(k) Program: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
The Special 510(k) Program: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
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
This Guidance Portal contains 4741 documents.