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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
Premarket Notification [510(k)] Submissions for Testing for Skin Sensitization To Chemicals In Natural Rubber Products - Guidance for Industry and FDA Reviewers/Staff  Food and Drug Administration (FDA) Final
Prescription Drug Marketing Act (PDMA) Requirements- Questions and Answers  Food and Drug Administration (FDA) Final
Prescription Drug Marketing Act — Donation of Prescription Drug Samples to Free Clinics  Food and Drug Administration (FDA) Final
Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products Guidance for Industry  Food and Drug Administration (FDA) Final
Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry  Food and Drug Administration (FDA) Final
Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements  Food and Drug Administration (FDA) Final
Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff  Food and Drug Administration (FDA) Final
Procedures for Field Testing Microwave Ovens  Food and Drug Administration (FDA) Final
Procedures for Laboratory Testing of Microwave Ovens  Food and Drug Administration (FDA) Final
Procedures for Renewal and Amendment of Certain Laser Light Show Variances (Laser Notice 55)  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.