The Additive Manufacturing Program in the FDA’s Center for Devices and Radiological Health (CDRH) conducts research on the effects of innovative manufacturing technologies to help ensure patient access to medical devices that are safe and effective. This is one of 20 research programs in CDRH’s Office of Science and Engineering Laboratories (OSEL).
Additive Manufacturing and Medical Devices
In the past decade additive manufacturing went from a niche manufacturing technology to the preferred manufacturing method for hearing aids and metal spine cages. To date, the FDA has cleared over 100 devices made using additive manufacturing technologies. While there are several other orthopedic, dental, and diagnostic applications utilizing the technology, the full promise of additive manufacturing has not yet been realized by the broader medical device community. Despite the full adoption of additive manufacturing in some product areas, regulatory science research in this space will spur medical device design, materials, and manufacturing innovation.
Regulatory Science Gaps and Challenges
The major regulatory science gaps and challenges that drive the Additive Manufacturing Program are:
- There is still a great deal of uncertainty on the testing and validation of the additive manufacturing process, especially when it comes to being predictive of medical device performance, therefore halting innovation, investments and adoption of additive manufacturing.
- Additive manufacturing represents a broad range of technologies involving hardware, software, and materials that are still rapidly evolving, which leads to continuous changes in the specifics of process validation and regulatory review burden.
- Additive manufacturing has simplified manufacturing to the point that clinicians and hospitals are looking to use the technology to enable manufacturing medical devices at the point of care and need guidance.
The Additive Manufacturing Program is intended to fill these knowledge gaps by fostering understanding of how additive manufacturing technologies affect the benefit-risk paradigm used to evaluate medical devices and by making the FDA better prepared for addressing devices additive manufacturing-related issues at both the premarket and postmarket stages in the medical device lifecycle.
Additive Manufacturing Program Activities
The Additive Manufacturing Program focuses on regulatory science research in these areas:
- Process validation and process monitoring activities for each advanced manufacturing technology type.
- Issues for adhering to quality system regulations, including performance testing to assess lattice structures in a least burdensome manner, and critical parameters for optimized topology.
- Software workflow to enable additive manufacturing, especially in patient-matched applications.
For more information, email OSEL_additivemanufacturing@fda.hhs.gov