#FDA Issues "Leap Frog" Guidance for 3D Printed Medical Devices | Pharma Industry Regulation | Scoop.it

The US Food and Drug Administration (FDA) has released a new draft guidance for medical device manufacturers working with additive manufacturing (AM), which is more commonly known as 3D printing.


In March, FDA approved the first-ever 3D printed drug, Aprecia's epilepsy drug SPRITAM, which relies on 3D printing technology to rapidly disintegrate in a patient's mouth, making it easier to swallow. For biologics, researchers are looking into 3D printing as a means of manufacturing cell and tissue products.


However, for medical devices, 3D printing technology is much farther along. So far, FDA has cleared more than 85 applications for 3D printed devices, though none have been for high-risk devices requiring premarket approval.


According to FDA, the "leap-frog" draft guidance is meant to provide manufacturers with the agency's initial thinking about the technical considerations for manufacturing 3D printed devices, as well as its thoughts on characterizing and validating such devices.


While additive manufacturing (AM) is a relatively new technology, FDA says it holds a number of advantages over traditional manufacturing processes for certain device applications.


"AM has the advantage of facilitating the creation of anatomically-matched devices and surgical instrumentation by using a patient's own medical imaging. Another advantage is the ease in fabricating complex geometric structures, allowing the creation of engineered porous structures, tortuous internal channels, and internal support structures that would not be easily possible using traditional (non-additive) manufacturing approaches," FDA writes.


However, FDA says that additive manufacturing also poses unique challenges when it comes to device characterization, validation and verification.


FDA says it wrote the draft guidance on the basis of feedback it received from a 2014 public workshop on challenges related to 3D printing. Some of the major takeaways from the workshop include the importance of material control, the impact of the 3D printer and post-printing processes on final device performance and the need for a "robust process validation and acceptance protocol."