Challenge: A division of a global molecular diagnostics company needed a regulatory strategy for a completely new technology.

Beaufort Solution: Division management had a clear plan for the scope of its product but lacked the regulatory expertise necessary to devise the most time-efficient and cost-effective approach for launching a new product. The company engaged Beaufort to develop a comprehensive regulatory strategy focusing on all aspects of the new technology, including biomarker targets and methodology. Beaufort provided a complete regulatory strategy that classified the device for the company including identification of potential predicate devices and assessed the possible pathways for the product, as well as timelines, associated tasks, and costs for each type of submission. The company is using this strategy to plan its current product development. In follow-up to the initial Regulatory Strategy for 510(k) submission, the company tasked Beaufort with providing a Regulatory Opinion. Specifically, the company provided 14 questions regarding its top priority and most controversial products due to the biomarker detection and Beaufort provided comprehensive answers to all of the questions.

Date posted: October 27, 2011

Categories: Case Studies Regulatory Affairs