Does your firm use 3D printing and UV Curing systems to manufacture medical devices..then you must validate these systems based on the new implemented Final FDA Guidance Document-“Technical Considerations for Additive Manufactured Medical Devices.”
On December 5, 2017, FDA issued the final version of the guidance, “Technical Considerations for Additive Manufactured Medical Devices.” Additive manufacturing (AM), the broad category of manufacturing encompassing 3-dimensional (3D) printing, is an emerging technology. This guidance is not intended to introduce new policy, but rather outlines the Agency’s current thinking about the technical aspects associated with AM processes, and provides manufacturers with recommendations for device design, manufacturing, and testing considerations for use when developing devices that include at least one additively manufactured component or additively fabricated step.
In medical device applications, AM has the advantage of facilitating the creation of anatomically-matched devices and surgical instrumentation by using a patient’s own medical imaging data. Another advantage is the ease in fabricating complex geometric structures, allowing the creation of engineered open lattice structures, tortuous internal channels, and internal support structures that would not be easily possible using traditional (non-additive) manufacturing approaches. However, the unique aspects of the AM process, such as the layer-by-layer fabrication process, combined with the relative lack of experience and clinical history with respect to devices manufactured using AM techniques, pose challenges in determining optimal characterization and assessment methods for the final finished device, as well as optimal process validation and verification methods for these devices. For devices manufactured using AM, the recommendations in this guidance supplement any device-specific recommendations outlined in existing guidance documents or applicable FDA-recognized consensus standards.
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