- Public Notification of Emerging Postmarket Medical Device Signals ('Emerging Signals') - Draft Guidance for Industry and Food and Drug Administration Staff
- Postmarket Management of Cybersecurity in Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff
- Implanted Blood Access Devices for Hemodialysis - Guidance for Industry and Food and Drug Administration Staff
- Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile - Guidance for Industry and Food and Drug Administration Staff
- Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff
- Applying Human Factors and Usability Engineering to Medical Devices - Guidance for Industry and Food and Drug Administration Staff
- Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices - Draft Guidance for Industry and Food and Drug Administration Staff
- List of Highest Priority Devices for Human Factors Review - Draft Guidance for Industry and Food and Drug Administration Staff
- Display Devices for Diagnostic Radiology - Draft Guidance for Industry and Food and Drug Administration Staff
- Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays - Guidance for Industry and Food and Drug Administration Staff
- Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices - Draft Guidance for Industry and Food and Drug Administration Staff
- Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization - Draft Guidance for Industry and Food and Drug Administration Staff
- Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes - Draft Guidance for Industry and Food and Drug Administration Staff
- 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
- Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices - Guidance for Industry and Food and Drug Administration Staff
- Emergency Use Authorization of Medical Products and Related Authorities, Guidance for Industry and Public Health Stakeholders - DRAFT GUIDANCE
- Radiation Biodosimetry Medical Countermeasure Devices - Guidance for Industry and Food and Drug Administration Staff
- Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices - Guidance for Industry and Food and Drug Administration Staff
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