- General Wellness: Policy for Low Risk Devices - Draft Guidance for Industry and Food and Drug Administration Staff
- Mitigating the Risk of Cross-Contamination from Valves and Accessories Used for Irrigation through Flexible Gastrointestinal Endoscopes - Draft Guidance for Industry and Food and Drug Administration Staff
- Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types - Draft Guidance for Industry and Food and Drug Administration Staff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Devices and Clinical Trial Design for the Treatment or Improvement in the Appearance of Fungally-Infected Nails - Draft Guidance for Industry and Food and Drug Administration Staff
- Current Good Manufacturing Practice Requirements for Combination Products: Draft Guidance for Industry and FDA Staff
- Premarket Studies of Implantable Minimally Invasive Glaucoma Surgical (MIGS) Devices - Draft Guidance for Industry and Food and Drug Administration Staff
- Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices - Guidance for Industry and Food and Drug Administration Staff
- Mobile Medical Applications - Guidance for Industry and Food and Drug Administration Staff
- Safety Considerations to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications - Guidance for Industry and Food and Drug Administration Staff
- Immediately in Effect Guidance Document: Classification and Requirements for Laser Illuminated Projectors (LIPs) - Guidance for Industry and Food and Drug Administration Staff
- Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices - Draft Guidance for Industry and Food and Drug Administration Staff
- Use of an Electronic Informed Consent in Clinical Investigations: Questions and Answers; Draft Guidance for Industry, Clinical Investigators, and Institutional Review Boards
- Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling - Guidance for Industry and Food and Drug Administration Staff
- Procedures for Meetings of the Medical Devices Advisory Committee - Draft Guidance for Industry and Food and Drug Administration Staff
You may also want to review some of my previous postings on this topic:
