Haselmeier Receives Medical Device Master File Number for Product Platform
Haselmeier officially announced it has received Master File Number MAF3202 from the US FDA for its D-Flex product platform, a new generation of injection pen systems for subcutaneous self-administration.
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 US 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. Pharmaceutical customers can now refer directly to the Master File Number MAF3202 when submitting their own products based on the D-Flex pen for approval, greatly simplifying and streamlining the FDA clearance process.
With this documentation in place, customers worldwide will be able to leverage the patent-registered D-Flex disposable pen system for their combination product development. This versatile, reliable platform is configurable for several fixed doses, bridging the gap between fixed and variable-dose pens, and can support pharmaceutical customers from clinical trials through to commercial use.
Konrad Betzler, Vice President Quality and Alexander Ball, Vice President IT, were involved in the FDA talks. As Mr Betzler comments, “We are delighted that global pharmaceutical customers can now benefit from this device master file submission. The file is a ‘living document’ that will evolve over the months and years ahead, in line with the latest D-Flex capacity and capability enhancements.”
In addition to the D-Flex injection system, Haselmeier also presented its D-Flex Connect system to the FDA. D-Flex Connect comprises the D-Flex pen, a smart cap, and an innovative, future-proof software platform. This development illustrates Haselmeier’s active commitment to digitalization. Following positive initial conversations with the FDA, Haselmeier plans to compile the data for either 510(k) or IDE submissions by the end of 2020, with the goal of enabling its customers to deploy D-Flex Connect in clinical trials.
As Mr Ball remarks, “We are grateful to the FDA for their active and encouraging participation in the meetings held so far. This is an important step for Haselmeier’s expansion into smart data management for therapy efficiency by building the D-Flex Connect platform.”
Haselmeier, headquartered in Switzerland, is a leading provider of subcutaneous injection system solutions. As a reliable development partner, Haselmeier provides customized solutions from concept design and prototyping to engineering and industrialization, including pharmaceutical packaging solutions. Haselmeier empowers safe self-administration of liquid drugs through the development and manufacture of intelligent injection devices that improve therapy efficiency. Moreover, the company is actively developing innovative connected solutions that will help shape the future of smart healthcare. Haselmeier currently employs 240 staff members in six countries with distribution offices in Europe, the US, and India, and state-of-the-art manufacturing plants in Buchen, Odenwald, Germany, Dnešice, Czech Republic, and Bengaluru, India. Haselmeier unites 100 years of experience in medical technology.
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