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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
Requesting FDA Feedback on Combination Products : Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Review Criteria for Assessment of C-Reactive Protein (CRP), High Sensitivity C-Reactive Protein (hsCRP) and Cardiac C-Reactive Assays: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Saline, Silicone Gel, and Alternative Breast Implants: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Submission and Resolution of Formal Disputes Regarding the Timeliness of Premarket Review of a Combination Product: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Surgical Masks - Premarket Notification [510(k)] Submissions: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Surveillance and Detention Without Physical Examination of Condoms: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Surveillance and Detention Without Physical Examination of Surgeons' and/or Patient Examination Gloves: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
The Least Burdensome Provisions: Concept and Principles: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
The Review and Inspection of Premarket Approval Application Manufacturing Information and Operations: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.