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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
Off-The-Shelf Software Use in Medical Devices: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Orthopedic Fracture Fixation Plates - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Orthopedic Non-Spinal Bone Plates, Screws, and Washers - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Pediatric Information for X-ray Imaging Device Premarket Notifications: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Peripheral Vascular Atherectomy Devices - Premarket Notification [510(k)] Submissions: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Policy Clarification for Certain Fluoroscopic Equipment Requirements: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Policy for Device Software Functions and Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.