The U.S. Food and Drug Administration (FDA) has approved more than 80 medical devices that involve 3D printing and one prescription drug. It also held a public workshop to obtain information and input about 3D printing issues on October 8 and 9, 2014. FDA brought together technical 3D printing expertise from various industries and sectors to help the agency develop an evaluation process for future submissions of medical devices resulting from additive manufacturing techniques. Based on the feedback from the workshop, FDA yesterday issued a draft guidance for Technical Considerations for Additive Manufactured Devices.
According to FDA, the draft guidance is a “leap-frog” guidance to share FDA’s “initial thoughts regarding technologies that are likely to be of public health importance early in product development.” While the draft guidance is not meant to be a comprehensive document to address all regulatory requirements, it highlights the technical considerations and recommendations for design, manufacturing, and testing of medical devices that include at least one fabrication step using additive manufacturing.
The guidance is split up into two categories of considerations: (1) design and manufacturing, and (2) device testing. Both sections overlap in substance, and the device testing section provides strong recommendations of what a device manufacturer should include in a premarket submission for a device that uses additive manufacturing. This will likely have an effect on how 3D printing device companies design, manufacture, and test their devices, especially those that manufacture patient-matched devices (devices that are “customized” for a specific patient’s anatomy, usually based on medical imaging data), to which the FDA draft guidance pays particular attention.
For more about legal issues involving 3D printed medical devices, read our white paper: 3D Printing of Medical Devices: When a Novel Technology Meets Traditional Legal Principles.