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HHS Guidance Documents
Title OpDiv/StaffDiv Sort descending Guidance Status Issue Date
Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Bone Anchors - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Breakthrough Devices Program: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Center for Devices and Radiological Health (CDRH) Appeals Processes: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Center for Devices and Radiological Health (CDRH) Appeals Processes: Questions and Answers About 517A: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Classification of Posterior Cervical Screw Systems: Small Entity Compliance Guide: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
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