What is modular submission?
The FDA approved CTI's "shell" (outline), which consists of only five separate data packages titled as follows:
-Module 1: Summary Data and Information (includes subsections covering corporate data, summary of safety and effectiveness, review of use of Computerized Thermal Imaging, indications for use, description of disease, patient population, alternate practices and procedures, etc.).
-Module 2: Device Characteristics (includes subsections on generic data, summary of safety and effectiveness, detailed description of data acquisition system, detailed description of clinical evaluation system, detailed description of software).
-Module3: Manufacturing Information (includes subsections covering every conceivable aspect of the manufacturing process from personnel through specs to production and process control to packaging and labeling to distribution and installation plus documentation and certification).
-Module 4: Non-Clinical Testing (includes subsections covering bench testing, bio-compatibility testing, electrical safety, electromagnetic compatibility, environmental assessment, reliability and durability, and stress and wear).
-Module 5: Clinical Study (includes subsections covering clinical protocol, objectives and hypothesis, details on the sites and investigators, patient population, statistical methods, effectiveness data, safety data, patient complaints, conclusions, and labeling).
The foregoing is a summary of the major data points required for the 5 modules. We are addressing several of the remaining modules on parallel tracks and have a significant refinement of the software underway at this time. Also, we will continue to collect clinical data at as fast a pace as is practical while completing modules 2,3,and 4. All in all, I am pleased with CTI's current pace. |
