Physician-Sponsored IDE (PS-IDE) offers an ability for the physicians to design the study to treat patients with the unapproved medical devices without the industry support or oversight. The unapproved devices may be born out of physician’s innovation (new devices) or innovative practice such as using the commercially available devices for unapproved indication (i.e., off-label use) or customizing/modifying the approved devices (altered device is considered a new device). Although there is a lot of freedom for the physician to design and conduct his or her own PS-IDE study, it is important to understand the regulatory requirements in every aspect of the trial that you will be personally responsible for. The study site will also have a unique challenge as it must incorporate sponsor obligations into their practices.
Yuki Kuramochi, BSN, RN, Clinical Project Manager, Cleveland Clinic