A device master file provides regulatory authorities with proprietary data about a material, component or manufacturing process. It enables the company submitting the information to the FDA to comply with regulatory requirements for trading in the USA while protecting its intellectual property from potential partners, competitors and customers. Moreover, it facilitates combination product approvals for multiple applications using the same device. Haselmeier formally submitted the MAF for D-Flex in late 2019, following productive discussions with the FDA.
