mdi Consultants
23
Jun
Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions (IDEs)
FDA requires an IDE prior to a sponsor initiating a clinical investigation for devices which FDA has determined to be Significant Risk. Through the IDE, the sponsor must demonstrate how the risks to the subjects are not outweighed by the anticipated benefits. If FDA is unable to determine that the benefits to the patients are