Success Stories

Learn how Greenleaf works with clients to devise effective solutions to their most complex regulatory challenges.

Planning and Supporting a Regulatory Strategy for De Novo and 510(k) Submissions

Greenleaf Health provided strategic and tactical advice to an early-stage start-up regarding their premarket submissions for a novel wound retraction system after the FDA determined that the company would need to follow the de novo pathway. The Greenleaf team assisted the company with development and submission of a de novo classification request for their product. During the review period, Greenleaf advised the company on how best to respond to the FDA’s requests for additional information and helped the company to prepare for meetings with the Agency. The company addressed the FDA’s concerns and was granted a de novo classification request for their first-generation device.  

While the first-generation device was undergoing de novo review, the company had begun to develop the second generation of their wound retraction system, which was the product intended for marketing. Having helped with the de novo submission, and possessing unique insight into the 510(k) process, the Greenleaf team was well-versed to develop a strategy for the company’s next premarket submission. Accordingly, Greenleaf supported the client throughout the development, submission, and review of its 510(k) application.  The company received 510(k) clearance for their second-generation device, which paved the way to a successful product launch in the United States.