To ensure the safety and efficacy of additively manufactured medical devices, the US Food and Drug Administration (FDA) has set up its own Additive Manufacturing Lab. The lab is part of the Office of Science and Engineering Laboratories (OSEL) within the FDA.
Over the past decade, additive manufacturing has evolved from a niche technology to the preferred production method for hearing aids and metal spinal implants. To date, the FDA has granted over 100 approvals for additively manufactured medical devices. Other orthopaedic, dental and diagnostic applications are already utilizing the technology. According to the FDA, however, the full potential of additive manufacturing has not yet been exploited.
With the new lab, the agency aims to clarify regulatory issues to spur innovation in medical device design, materials and manufacturing.
The FDA’s key challenges include the inadequate validation and monitoring of additive manufacturing processes and the associated uncertainties in predicting the performance of medical devices. The constant further development of hardware and software makes it difficult to make appropriate adjustments to approval tests.
The overarching goal of the Additive Manufacturing Program is to close knowledge gaps regarding the technology and thus improve the assessment of the risk-benefit ratio. It also aims to improve FDA preparation for issues relating to additive manufacturing – both before and after market launch.