Factors To Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions; Draft Guidance for Investigational Device Exemption Sponsors, Sponsor-Investigators, and Food and Drug Administration Staff; Availability

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions (IDEs).'' The purpose of this draft guidance is to provide greater clarity for FDA staff and IDE sponsors and sponsor- investigators regarding the principal factors that FDA considers when assessing the benefits and risks of IDE applications for human clinical study. The draft guidance also characterizes benefits in the context of investigational research, which includes direct benefits to the subjects and benefits to others (to the extent they are indirect benefits to subjects or reflect the importance of knowledge to be gained). This draft guidance is not final nor is it in effect at this time.