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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
Providing Information about Pediatric Uses of Medical Devices: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Public Warning-Notification of Recalls Under 21 CFR Part 7, Subpart C : Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Quality System Information for Certain Premarket Application Reviews : Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Real-Time Premarket Approval Application (PMA) Supplements: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
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
This Guidance Portal contains 4741 documents.