Elements of a clinical trial protocol for medical devices

Abstract

Based on a Class 2 limited risk hospital based clinical trial, and a subsequent project retrospective, Briggs and Ramer propose an expanded clinical trial protocol. Such an expanded protocol would be especially helpful for evaluating De Novo devices: new inventions which require new processes for full hospital integration. Since these new processes would often require training of nurses and supporting professionals, Briggs and Ramer suggest that nurse investigators could be very effective in carrying out such expanded protocol studies. We briefly describe the FDA approval process, the role of the nurse in evidence based medical device evaluation, the Ramer, et al. clinical trial, the proposed expanded clinical trial protocol, and candidate categories of devices that might employ the limited risk Class 2 Medical Device clinical trial protocol. The investigators look forward to carrying out such a medical device clinical trial in the near future.