Description

This BioUtah Workshop will provide information regarding the classification of medical devices by the FDA, how to obtain FDA’s classification when your device doesn’t fit neatly into an established classification for your device type, and how to obtain FDA’s feedback on your proposed product development activities to assure they will result in a successful FDA submission (510(k), IDE/PMA, de novo Petition). In particular, the workshop will address issues such as:

 What is the Classification for my device?

 How can I assure the classification I have made for my device is correct?

 How can I determine if the FDA agrees with the clinical investigation or design verification plan that I will use to establish the safety and efficacy of my device?

 How can I assure the FDA will accept my submission for review?

 How can I prepare the required eCopy of my FDA Submissions?

The Workshop will be most beneficial to:

 All employees of start-up companies

 Regulatory Affairs personnel who have to prepare 513(g) or pre-submission (Q Sub) materials

 Inventors, Sr. Management and Design and Development Engineers interested in knowing the classification of their medical devices and the consequent FDA requirements for marketing them in the US