How can I participate in medical device clinical trials normally open only to broad scope medical use licensees?
Frequently, a limited scope medical use licensee applies for authorization to participate in clinical trials using a source or device that has not been reviewed and approved by the NRC or an Agreement State. Such a licensee may consider one of the following approaches to assuring compliance with NRC requirements: • Ask the trial sponsor to have its source or device evaluated and registered by NRC or an Agreement State, and submit their application to participate in the trials after the source or device is registered; Submit an application that requests a “custom” review of the source or device from NRC. This provides NRC with all the necessary information for this review, but delays authorization to participate in the trial(s) until the source or device review is successfully completed; Submit an application that requests authorization for the limited scope medical use Radiation Safety Committee to perform the requisite radiation safety and engineering review of the source and/or devic
