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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
Dental Curing Lights - Premarket Notification [510(k)]: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Dental Handpieces - Premarket Notification [510(k)] Submissions: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Devices Used to Process Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Enforcement Policy Concerning Certain Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Exemption from Reporting and Recordkeeping Requirements for Low Power Laser Products (Laser Notice 54): Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
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
This Guidance Portal contains 4741 documents.