Greenleaf Health worked with a major orthopedic company to gain marketing authorization for a new formulation of an approved bone augmentation product. Due to the complex regulatory and scientific nature of this project, Greenleaf coordinated with a large team of in-house and external regulatory and scientific experts in order to devise the most advantageous strategy for the company’s product. The Greenleaf team developed a strategic regulatory plan to pursue a premarket approval (PMA) Panel Track Supplement for the new formulation.
The company needed to address several difficult questions from the FDA regarding study endpoints, radiographic methods, and statistical analyses, as well as navigate differences between the review requirements of the Premarket and Postmarket Offices within the Center for Devices and Radiological Health (CDRH). Greenleaf helped the company to satisfactorily respond to the Agency and realign the submission from an original PMA to a PMA Panel Track Supplement. With Greenleaf’s support, the company was able to satisfy the FDA’s safety and effectiveness requirements without conducting a new clinical study, saving them valuable time and resources.