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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
Impact-Resistant Lenses: Questions and Answers: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
IND Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Infusion Pumps Total Product Life Cycle: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Intravascular Administration Sets Premarket Notification Submissions [510(k)]: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Investigational Device Exemptions (IDEs) for Devices Indicated for Nocturnal Home Hemodialysis: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Keratome and Replacement Keratome Blades Premarket Notification [510(k)] Submissions: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Medical Device Tracking : Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.