Following the IDEAL workshop at Rhodes House in December 2010, Dr Art Sedrakyan (Cornell University) and Dr Danica Marinac-Dabic (FDA) have proposed, funded and arranged a meeting where the FDA will debate the value of the IDEAL framework in planning the revision to the FDA’s regulatrory strategy for devices following the Institute of Medicine report on the “510k” system.
The meeting will debate the needs of the regulatory system, and the ways in which a system like IDEAL could guide the development of appropriate guidelines for investigations required at different stages of the product life-cycle.
- Setting the stage
- Discussion: Leveraging the accumulated evidence
- Premarket evidence generation and evaluation for surgical medical devices
- Discussion: Optimizing an integrated total product life cycle for devices and procedures
- Conditional approval
- Innovative approaches for postmarket evaluation.