Clinical Trials - Medical Device FDA's Program 2017

The topic is device clinical trials. This term refers to the use of medical products on/in humans, in order to gain useful knowledge about the product.

Why should you Attend:

In spite of the long experience device companies have with clinical trials regulations (published 25 years ago), many companies have found this area an expensive trap. In fact, the only thing more expensive than a good clinical trial is a bad clinical trial.

Areas Covered in the Session:

• Valid Scientific Evidence
• Phases of Device Human Studies
• Significant/Non-Significant Risk
• IDE Meaning, Content, Review
• Exemption from IDE rules

Who Will Benefit:

• R&D and Regulatory Staff
• Management of R&D Regulatory