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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
Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation - Non-clinical Testing and Clinical Considerations: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
In Vitro Companion Diagnostic Devices: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings - Labeling Considerations: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Laser Products - Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56): Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Logical Observation Identifiers Names and Codes for In Vitro Diagnostic Tests : Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Magnetic Resonance (MR) Receive-only Coil - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.