Docket Management
Docket: 02N-0445 - FDA Regulation of Combination Products
Registration Number: EAPE -57

Accepted - Volume 3

Registration for FDA Regulation of Combination Products
Name Mr. Mark Hamblin
Organization Carnegie Mellon University

1. Brief statement of the general nature of the views you wish to present. As part of a project course at Carnegie Mellon University, I am developing a decision support tool to aid in the FDA's process of determining a medical product's primary mode of action and assigning primary jurisdiction between centers. The tool will help make this process more predictable, consistent, and transparent. The final results of this project will be presented to the FDA in the beginning of December.
2. The names and address of all persons who will participate in the presentation. Mark Hamblin -- 5033 Forbes Avenue, Pittsburgh, PA 15213
3. Approximate time that you request to make your presentation. 15 minutes
4. Special Accommodations required. Please specify. Technical Requirements - projector/screen for computer presentation

EAPE -57