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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
Early Development Considerations for Innovative Combination Products: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Application of Human Factors Engineering Principles for Combination Products: Questions and Answers: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
The Use of Clinical Holds Following Clinical Investigator Misconduct: Guidance for Industry and Clinical Investigators  Food and Drug Administration (FDA) Final
Guidance on the Department of Defense Exemption from the FDA Performance Standard for Laser Products: Guidance for Industry and FDA  Food and Drug Administration (FDA) Final
Investigational Device Exemption (IDE) Guidance for Retinal Prostheses: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Collection of Platelets by Automated Methods: Guidance for Industry and FDA Review Staff  Food and Drug Administration (FDA) Final
30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Acceptable Media for Electronic Product User Manuals: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Addition of URLs to Electronic Product Labeling: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Application User Fees for Combination Products: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.