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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
Guidance for Industry: Regulatory Framework for Substances Intended for Use in Human Food or Animal Food on the Basis of the Generally Recognized as Safe (GRAS) Provision of the Federal Food, Drug, and Cosmetic Act  Food and Drug Administration (FDA) Final
Recommendations for the Submission of LOINC® Codes in Regulatory Applications to the U.S. Food and Drug Administration: Guidance for Industry  Food and Drug Administration (FDA) Final
Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 Guidance for Industry  Food and Drug Administration (FDA) Proposed
Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients Upon Request: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Product Labeling for Certain Ultrasonic Surgical Aspirator Devices: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Pediatric Gastroesophageal Reflux Disease: Developing Drugs for Treatment Guidance for Industry  Food and Drug Administration (FDA) Proposed
Deciding When to Submit a 510(k) for a Change to an Existing Device: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Deciding When to Submit a 510(k) for a Software Change to an Existing Device: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
CVM GFI #235 Current Good Manufacturing Practice Requirements for Food for Animals  Food and Drug Administration (FDA) Final
Draft Guidance for Industry: Application of the “Solely Engaged” Exemptions in Parts 117 and 507  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 5495 documents.