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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
Writing Dear Doctor Letters for Recalls of Implantable Cardioverter Defibrillators (ICDs): Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
“Harmful and Potentially Harmful Constituents” in Tobacco Products as Used in Section 904(e) of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Biomarker Qualification: Evidentiary Framework: Draft Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Proposed
Glass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4: Draft Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Proposed
Predetermined Change Control Plans for Medical Devices: Draft Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Proposed
Submissions for Postapproval Modifications to a Combination Product Approved Under a BLA, NDA, or PMA: Draft Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Proposed
Classification and Requirements for Laser Illuminated Projectors (LIPs) (Laser Notice No. 57): Guidance for Industry and Food and Drug Administration  Food and Drug Administration (FDA) Final
Multiple Function Device Products: Policy and Considerations: Guidance for Industry and Food and Drug Administration  Food and Drug Administration (FDA) Final
Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration  Food and Drug Administration (FDA) Final
Acceptance and Filing Reviews for Premarket Approval Applications (PMAs): Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4742 documents.