- Collaborative Communities: Addressing Healthcare Challenges Together
- Webinar: Collaborative Communities – October 29, 2019
- FDA in Brief: FDA announces participation in first two ‘Collaborative Communities’ working to develop solutions to medical device innovation challenges
- Framework for the Safety and Performance Based Pathway
- Webinar – Safety and Performance Based Pathway Performance Criteria – November 7, 2019
- Safety and Performance Based Pathway – Guidance for Industry and Food and Drug Administration
- Cutaneous Electrodes for Recording Purposes – Performance Criteria for Safety and Performance Based Pathway – Draft Guidance for Industry and Food and Drug Administration Staff
- Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway – Draft Guidance for Industry and Food and Drug Administration Staff
- Spinal Plating Systems – Performance Criteria for Safety and Performance Based Pathway – Draft Guidance for Industry and Food and Drug Administration Staff
- Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Program for Medical Devices (Medical Product Safety Network)
- Federal Register: Safety and Performance Based Pathway Device-Specific Guidance; Draft Guidances for Industry and Food and Drug Administration Staff
Several US FDA draft guidances, including some specific device guidances for the Safety and Performance Based Pathway
Published in Draft Guidance, Safety and Performance Based Pathway and United States Food and Drug Administration - US FDA
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- US draft guidance – Soft (Hydrophilic) Daily Wear Contact Lenses – Performance Criteria for Safety and Performance Based Pathway
- US FDA Update on Laparoscopic Power Morcellators – actions and draft guidance
- US FDA Draft Guidance – FDA Issues Draft Guidance on Arthroscopy Pump Tubing Sets
- US FDA Draft Guidance – Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters – Premarket Notification (510(k)) Submissions
- TGA – IVD companion diagnostics – Guidance on proposed regulatory requirements
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- EU – Team-NB Position Paper on Documentation Requirements for Drug Device Combination Products Falling in the Scope of Article 117 of MDR 2017/745.
- US – FDA Issues Immediately in Effect Guidance on Ventilators During COVID-19
- US – Ventilator Supply Mitigation Strategies – Letter to Health Care Providers
- US – Update on the Ethylene Oxide Sterilization Master File Pilot Program
- US – FDA Engagement to Mitigate Potential Shortage of Personal Protective Equipment (PPE)
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