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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
FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND: Frequently Asked Questions: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
General Principles of Software Validation: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Hemodialysis Blood Tubing Sets - Premarket Notification [510(k)] Submissions: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
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
This Guidance Portal contains 4735 documents.