An Investigational Device Exemption is essentially an FDA permit to conduct a clinical study. Taking the definition to its most basic level, this "permission" is necessary any time a medical product that is not yet cleared for marketing will be used in or for the benefit of human beings. An IDE is not a set of application forms. Rather, it is a compilation of plans, drawings, test reports, literature reviews, study protocols, procedure manuals and much more.

Buckman Company, Inc. has prepared hundreds of IDE's for products to be reviewed by the Cardiovascular, Orthopaedic, Ophthalmology, Anesthesiology, Obstetric/Gynecologic and other branches of FDA. We will provide a template for you to prepare the submission yourself, write the full document for you, or review and comment on a submission that you have prepared yourself.