Webinar Materials

• Presentation
• Slide Deck #1: Webinar - An Update on the FDA’s Medical Device Clinical Trials Program - July 14, 2016
• Slide Deck #2: Clinical Trials Update: Early Feasibility Study Investigational Device Exemptions
• Slide Deck #3: Clinical Trials Update: Draft Guidance: FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions
• Transcript

The FDA held a webinar on July 14, 2016 for an update on two key activities from the CDRH Office of Device Evaluation Clinical Trials Program:

• Early Feasibility Studies
• Draft Guidance: FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicaid Services (CMS) with Coverage Decisions

Target audience: Industry

If you have general questions about the CDRH clinical trials program, please contact CDRH’s Division of Industry and Consumer Education (DICE) at [email protected], 1-800-638-2041, or 301-796-7100.

Food and Drug Administration
Center for Devices and Radiological Health