Feasibility and Early Feasibility Clinical Studies for Certain Medical Devices Intended to Therapeutically Improve Glycemic Control in Patients with Type 2 Diabetes Mellitus: Guidance for Industry and Food and Drug Administration Staff
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
May 6, 2022
May 5, 2022
beb50e65-0eb4-41d4-adac-bdf7103fa447
Related Documents
Medical Devices with Indications Associated with Weight Loss - Premarket Considerations: Guidance for Industry and Food and Drug Administration Staff
Guidance DocumentMarch 13, 2026Center for Devices and Radiological Health
Clinical Investigations for Prostate Tissue Ablation Devices: Guidance for Industry and Food and Drug Administration Staff
Guidance DocumentJuly 15, 2020Center for Devices and Radiological Health
Mouse Embryo Assay for Assisted Reproduction Technology Devices
Guidance DocumentJanuary 5, 2021Center for Devices and Radiological Health
Quick Actions
Transform Regulatory Data into Actionable Intelligence
Join leading pharmaceutical and medical device companies who trust GKS for their regulatory compliance needs.
Try KeyPedia Today
Explore our real use cases and discover our features in depth.
Subscribe to our newsletter
Get the latest updates and insights delivered to your inbox