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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
Third Party Review Guidance For Vitreous Aspiration and Cutting Device Premarket Notification (510(k))  Food and Drug Administration (FDA) Final
Variance from Manufacturer Report Number Format - No. 5  Food and Drug Administration (FDA) Final
Variance from Manufacturer Report Number Format [MDR letter]  Food and Drug Administration (FDA) Final
Withdrawn Guidances (Biologics)  Food and Drug Administration (FDA) Final
1993 Draft Redbook II  Food and Drug Administration (FDA) Proposed
Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 Guidance for Industry  Food and Drug Administration (FDA) Proposed
CPG Sec 555.320 Listeria monocytogenes  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry and FDA Staff: Whole Grain Label Statements  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Regulatory Procedures Manual Chapter 9 Subchapter on Recommending Customs' Seizure and Destruction of Imported Human and Animal Food That Has Not Been Reconditioned  Food and Drug Administration (FDA) Proposed
Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4735 documents.