By Karl Kapp
The case for 3D printing within the medical device field is strong. The act of 3D printing, for those who might not know, is the process of creating a physical object from a three-dimensional digital model through the layering of the material until an object is created. The advantage is that the cost of 3D printing makes it economical to create a one-off 3D item customized to any individual need. And there have been some dramatic examples of 3D printing of medical devices and medical related materials.
For example, the FDA provides a case study from a hospital in Michigan where they created and implanted a 3D printed medical device into a 3-month-old boy with a rare bronchial condition and saved his life. There is even a volunteer group called e-NABLE which creates 3D printed prosthetics for those in need. While these initiatives hold great potential, it opens up an entire new area that requires monitoring and evaluation.
So, with the advent of 3D printing, the FDA has indicated that 3D printing seems to have application in the following areas:
- Medical devices regulated by FDA’s Center for Devices and Radiological Health (CDRH),
- Biologics regulated by FDA’s Center for Biologics Evaluation and Research (CBER), and
- Drugs regulated by FDA’s Center for Drug Evaluation and Research (CDER).
In May of 2016, the FDA issued draft guidance on the Technical Considerations for Additive Manufactured Devices (3D printing) to advise manufacturers who are producing devices through 3D printing techniques. This draft guidance has been published to obtain public feedback and is not final or in effect at this time. So, if you are considering 3D manufacturing of medical devices, you may want to take a look.
The FDA is currently evaluating submissions for new 3D printed medical devices to determine safety and effectiveness. The draft guidance provides manufacturers with recommendations for device design, manufacturing, and testing considerations when developing 3D printed devices. The type of premarket submission required for a device is still determined by its regulatory classification.
The draft guidance on 3D medical devices is broadly organized into two topic areas by the FDA.
Design and Manufacturing Considerations:
This section of the guidance provides technical considerations that should be addressed as part of fulfilling Quality System (QS) requirements for a device, as determined by its regulatory classification or regulation to which it is subject, if applicable. While this draft guidance includes manufacturing considerations, it is not intended to comprehensively address all considerations or regulatory requirements to establish a quality system for the manufacturing of a device.
Device Testing Considerations:
This section of the guidance describes the type of information that should be provided in premarket notification submissions [510(k)], premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, de novo requests and investigational device exemption (IDE) applications for a 3D printed device.