Regulatory support - US market for innovative breast cancer diagnostic test

Purpose and goal

The purpose of the project is to acquire the knowledge needed to effectively write and submit a submission to the US Food and Drug Administration (FDA) regarding an innovative in vitro diagnostics product. An approval from FDA is a prerequisite for selling and marketing a medical device in the US market.

Expected results and effects

The project has gone according to plan and given the company the necessary knowledge to be able to submit a successful sybmission to the FDA. For the company, an FDA approval is important and is a prerequisite for being able to market and sell DiviTum for clinical use in the USA.

Planned approach and implementation

The Vinnova grant has been used to secure relevant expertise necessary for the FDA submission. During the project, consultants have contributed to the company´s work to establish the FDA submission. The consultants have trained the company´s staff and have provide advice and consulting assistance in the work with regard to the technical documentation.