3D Printed medical devices are a new frontier in healthcare, and the FDA is struggling to understand the best way to regulate them. This past May, the agency released a draft guidance about 3D printed medical device regulations and asked experts from both the 3D printing and medical device industries to comment.

While the draft guidance initially inspired very few comments, several leaders in the 3D medical printing industry have stepped in to provide valuable insight. The Belgium-based 3D printing giant Materialise led the pack with thorough suggests on the proposed regulations. Materialise echoed the concerns of several other companies by asking the FDA to provide a separate guidance for patient-specific 3D printed medical devices and for one size fits all 3D printed medical devices.

Companies like Materialise utilize data and measurements from imaging like CT scans to create individualized computerized 3D models that can be fabricated on 3D printers. This approach allows for medical devices to be tailored to exact specifications of each individual patient.

Materialise also asked the FDA to consider a risk-based approach with regard to quality management standards. In a more general comment, the company also asked the FDA not to subject 3D printed medical devices to higher standards than other types of medical devices.

But 3D printing for patient-specific devices opens the door to more concerns. The Advanced Medical Technology Association asked the FDA to clarify its position on the handling of patient specific data.

Healthcare giant Johnson & Johnson (J&J) also jumped in on the comments with several suggestions of its own. J&J has a stake in 3D printing technology since partnering with both Materialise and Hewlett-Packard to produce 3D printed medical devices. Additionally, J&J is collaborating with more than 50 other companies, government agencies, and academics to produce 3D printed devices.