If you have a new medical technology and are unsure of where to start on the road to the US market, GEMAR is uniquely qualified to assist you.
We will help you determine how the product is classified and to develop the best way to proceed. If it is a Class III device requiring a clinical study as part of the PMA, our understanding of clinical study design and monitoring will be invaluable, whether the device is considered to be significant-risk, and thus require an Investigational Device Exemption prior to proceeding, or not. We are experienced in the nuances of preparing for and participating in meetings with the FDA review division and will be with you every step of the way.
We are prepared to assist you in the compilation of the necessary PMA documentation for the safety and effectiveness determination.