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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
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
Humanitarian Device Exemption (HDE) Program: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Humanitarian Use Device (HUD) Designations : Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Implanted Blood Access Devices for Hemodialysis: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
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
This Guidance Portal contains 3999 documents.