Investigational Device Exemption
An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data to support a 510(k) or Premarket Approval Application. Investigational use also includes clinical evaluation of certain modifications or new intended uses of legally marketed devices. All clinical evaluations of investigational devices, unless exempt, must have an approved IDE before the study is initiated. Clinical evaluations of devices include an IDE approved by the Institutional Review Board (IRB) and approval by the FDA if the study involves significant risk, informed consent by all patients, labeling that states "for investigational use only", monitoring, and required records and reports.
A sponsor of a significant risk device study must submit a complete IDE application to FDA. There are no preprinted forms for an IDE application; however, an IDE application must include certain required information. This involves a long list of items, including report of prior investigations; an investigational plan; description of methods, facilities, controls; examples of the agreement and signatures from involved parties; Pre-IDE information and meetings; waiver requests, etc.
Methodize can help your company submit a thorough and effective IDE application. We know the formatting required by the FDA and how to avoid common problems with IDE applications.