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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Sort descending Guidance Status Issue Date
General Principles of Software Validation: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Global Unique Device Identification Database (GUDID): Data Submission Compliance Date of September 24, 2015: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices: 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
Intravascular Administration Sets Premarket Notification Submissions [510(k)]: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
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