Subcutaneous self-injection device receives master file number

Haselmeier, a solutions provider for subcutaneous self-injection devices, has received Master File Number MAF3202 from the Food and Drug Administration (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 information about a material, component or manufacturing process. This file will enable Haselmeier to comply with the regulatory requirements for trading in the USA, whilst also protecting the organization’s intellectual property from potential partners, competitors and customers. It also facilitates combination product approvals for multiple applications using the same device.

With this documentation in place, customers all over the world will be able to leverage the patent-registered D-Flex disposable pen system for their combination product development. This device has the ability to be configured for several fixed doses and therefore aims to bridge the gap between fixed and variable-dose pens. The device also hopes to support pharmaceutical customers from clinical trials through to commercial use.