The project aims to develop a comprehensive regulatory strategy for Meiotic Inc.'s innovative smartphone-based malaria detection technology. This project will focus on navigating the FDA approval process and designing an early-stage clinical trial. The goal is to ensure that the product meets all regulatory requirements for market entry in the United States. Students will conduct in-depth regulatory research to understand the FDA's pathway for medical devices, particularly those utilizing smartphone technology. They will map out the submission route, identifying key milestones and potential challenges. Additionally, students will propose a design for an early clinical trial, considering factors such as participant selection, trial duration, and data collection methods. This project provides an opportunity for learners to apply their classroom knowledge of regulatory affairs and clinical trial design in a real-world context.

The deliverables for this project include a detailed regulatory plan outlining the FDA submission process and key considerations. Students will also create a trial design brief that proposes a structure for the early clinical trial. Finally, an executive summary will be prepared to present the overall strategy and recommendations to Meiotic Inc.'s leadership team. These deliverables will demonstrate the students' ability to synthesize regulatory information and design a feasible trial plan.