FDA Releases Draft Guidance On Investigational Device Exemptions

The FDA is releasing a draft guidance on the factors it considers when making benefit-risk determinations for investigational device exemptions (IDEs).

The draft guidance should provide greater clarity for Food and Drug Administration staff and IDE sponsors and sponsor-investigators regarding the principal factors that the FDA considers when assessing the benefits and risks of IDE applications for human clinical study, the agency said. The draft guidance also characterizes benefits in the context of investigational research, which includes direct benefits to the subjects and benefits to others.

The agency announced the draft in a notice published June 18 in the Federal ...