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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Sort descending Guidance Status Issue Date
Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Recommendations for Sponsors Requesting EUAs for Decontamination and Bioburden Reduction Systems for Face Masks and Respirators During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug…  Food and Drug Administration (FDA) Final
Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Refuse to Accept Policy for 510(k)s: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Reporting of Computational Modeling Studies in Medical Device Submissions: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling : Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Safety Considerations to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
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