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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
Mammography Quality Standards Act and Regulation Amendments: Small Entity Compliance Guide: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients Upon Request: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Manufacturing Site Change Supplements: Content and Submission: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Marketing Clearance of Diagnostic Ultrasound Systems and Transducers : Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Medical Device Reporting for Manufacturers : Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Medical Devices and Clinical Trial Design for the Treatment or Improvement in the Appearance of Fungally-Infected Nails: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices): Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Medical X-Ray Imaging Devices Conformance with IEC Standards: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Metal Expandable Biliary Stents - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.