Regulatory affairs

Abstract

On May 17, 1989, FDA issued its 'Guidance on the Review of Investigational Device Exemptions (IDE) Applications for Feasibility Studies,' in which it announced its willingness to use greater flexibility in the regulation of medical device feasibility studies. In that guidance, FDA expressed its desire to work closely with sponsors of medical device research to reduce the burden of IDE regulations in cases in which only basic design and operating specifications are tested. This article examines briefly the impact of IDE regulations on medical research and discusses some of the propsals - including FDA's guidance - for lessening that impact.