CPhI Online

- Market News

Haselmeier receives medical device Master File Number for its injection pen systems

17 Mar 2020

This documentation will enable customers worldwide to leverage the D-Flex disposable pen system for their combination product development.

Haselmeier has received Master File Number MAF3202 from the US Food and Drug Administration (FDA) for its D-Flex product platform, a new generation of injection pen systems for subcutaneous self-administration.

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.

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. 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.

Related Content