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HHS Guidance Submissions

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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
Mitigating the Risk of Cross-Contamination from Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Molecular Diagnostic Instruments with Combined Functions: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Nonbinding Feedback After Certain FDA Inspections of Device Establishments: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Off-The-Shelf Software Use in Medical Devices: 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
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