FDA regulators released new guidance for how the organization plans to regulate the 3-D printing of medical devices, according to Medical Design & Outsourcing.
Here are five things to know:
1. The new guidance clarifies what FDA regulators want to see in submissions for FDA approval. The new guidelines include plans to regulate 3-D printing in non-traditional settings, such as medical facilities and academic institutions.
2. What the FDA describes as a "leapfrog guidance" offers initial thoughts on the industry. The new guidance includes FDA regulators' thinking on a device design, function and durability as well as quality system requirements regarding 3-D printing.
3. The guidance document also states:
• Patient-specific device design must take into account the effects of imaging used to create proper fit, how modifications interact with design models, design file complexity, cybersecurity and how personally identifiable information will be handled.
• Quality may vary when an identical medical device or component is designed using different additive manufacturing machines, even when using the same machine model.
• Changes to the device, manufacturing process of process deviations may trigger the need for a revalidation depending on potential risk.
4. Concerning the overall design, the FDA recommends a comparison of the desired feature sizes of a final finished device to minimize possible feature size of a 3-D printing technique and the manufacturing tolerance of the individual machine. The FDA wants to ensure devices can be rebuilt to specific dimensions
consistently.
5. FDA Commissioner Scott Gottlieb said in a statement, "In order to help ensure the safety and effectiveness of these products, we're working to establish a regulatory framework for how we plan to apply existing laws and regulations that govern device manufacturing to non-traditional manufacturers…. that create 3-
D printed personalized devices for specific patients they are treating."