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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date Sort descending
1993 Draft Redbook II  Food and Drug Administration (FDA) Proposed
Guidance on Premarket Notification [510(k)] Submissions for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care Facilities  Food and Drug Administration (FDA) Final
Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes  Food and Drug Administration (FDA) Final
Revised Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV)  Food and Drug Administration (FDA) Final
Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators  Food and Drug Administration (FDA) Final
Guidance for Industry: Guidelines for Determining Metric Equivalents of Household Measures  Food and Drug Administration (FDA) Final
Guidance on the Content and Format of Premarket Notification [510(k)] Submissions for Sharps Containers  Food and Drug Administration (FDA) Final
Manufacturers/Assemblers of Diagnostic X-ray Systems: Enforcement Policy for Positive-Beam Limitation (PBL) Requirements in 21 CFR 1020.31(g) :  Food and Drug Administration (FDA) Final
Letter - Manufacturers, Distributors and Importers of Condom Products (included in Condom Packet 398) : Letter - Manufacturers, Distributors and Importers of Condom Products  Food and Drug Administration (FDA) Final
Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone Or Bone Cement  Food and Drug Administration (FDA) Final
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