On December 5, 2017, the U.S. Food and Drug Administration (FDA) released the final version of its guidance entitled “Technical Considerations for Additive Manufactured Medical Devices; Guidance for Industry and Food and Drug Administration Staff.” As a follow up to the Guidance’s release the FDA held a webinar on January 10, 2017, to present an overview of the Guidance and answer questions. The presentation was a joint effort from several offices within the FDA’s organization and presenters included FDA employees, Matthew Di Prima, James Coburn (both of the Office of Science and Engineering Laboratories), Eric Horowitz (Office of Science and Engineering Laboratories), David Hwang, Joel Anderson (both of the Office of Device Evaluation) and Nooshin Kiarashi (Office of In Vitro Diagnostics and Radiological Health).
The webinar highlighted the technical assessments that manufacturers of certain 3D printed medical devices should consider when submitting a premarket application for a medical device that includes at least one fabrication step using additive manufacturing. As a helpful tool, the FDA used a hypothetical example of a 3D printed cranial implant device to walk through the information that the FDA would require in a premarket application for such a device. FDA has plainly put a lot of time into thinking about the unique technical aspects involved in 3D printing of medical devices and ensuring that the manufacturers of those devices consider these issues when submitting a premarket application.
For more about the FDA Guidance, please see: Observations on FDA 3D Printing Guidance and FDA Publishes Draft Guidance Regarding 3D Printing Of Medical Devices. For more on general legal issues involving 3D printed medical devices, please see: 3D Printing of Medical Devices: When a Novel Technology Meets Traditional Legal Principles, 3D Printing of Manufactured Goods: An Updated Analysis, and 3D Printing: What Could Happen to Products Liability When Users (and Everyone Else in Between) Become Manufacturers”.