FDA Seeking Comment on 3D printed Medical Devices

The FDA is seeking comment on 3D printed medical devices, in its Discussion Paper. 3D Printing Medical Devices at the Point of Care: Discussion Paper | FDA

From this Discussion Paper, it is clear that the FDA is interested in understanding how to implement policy on this cutting-edge assortment of medical devices that have very versatile uses.  The versatility of these devices is the defining factor, in my opinion, that differentiate 3-D printed device design from traditional medical device design.  By not placing specific design parameters on the finished product for patient use, one must ensure that proper design controls, if applicable, are implemented to ensure safety and effectiveness.

This discussion paper poses three scenarios of ways that 3-D printing may be established in a point-of-care setting, and then asks specific questions for discussion about how one might implement the necessary controls around medical device production, so the product can be quickly delivered to the patient, while still maintaining safe and effective product.

It takes longer to ready than one might like, but since the goal is to spur meaningful discussion around the key questions some of the scenarios require detailed examples to set the stage for each discussion question.  The better answers will help FDA to formulate a more comprehensive policy around this special innovation in medical device technology.  I encourage you to look at it and use creative problem-solving to decide how you might address the open questions.