FDA in talks to regulate 3D printed medical devices to ensure correct care

3D printing is changing manufacturing in many different industries. The medical industry discovered the value of 3D printing in the 1990s, using the technology to create dental implants and custom prosthetics. Today, 3D printing is being used in cancer research, to print surgical tools, and to create organs and skin for transplant. The FDA regulates medical devices, including those printed through 3D technology.

Traditionally, healthcare providers who need 3D printed devices would send the information to a manufacturer and wait for the device to be made and sent back. With 3D printing technology becoming more available, more healthcare facilities (HCFs) have the capability to print devices at the point of care. The FDA recognizes that this is a significant development for the medical industry. To that end, the FDA is engaging in a discussion to establish the framework for regulations to print medical devices at the point of care.

Key points of discussion for medical 3D printing

The FDA published a discussion paper to drive the conversation on regulatory oversight. The 19-page document includes information about the history of 3D printing in medical devices and the regulations by the FDA to date.  It also gives examples of regulatory oversight, but this document is not meant to provide regulations, just to start the conversation. The concerns:

• Make sure 3D printed devices printed at the point of care are safe and effective. Many HCFs entering 3D printing may not be aware of the regulations about manufacturing medical devices.
• Assuring that product specs are met. The regulations for 3D devices are less defined than for those made with traditional manufacturing.
• Clarifying responsibility. A medical device can go through many hands before it gets to the patient, from design to quality control and adverse events. There are concerns about who is responsible for each of these activities.
• Knowledge and training. The FDA wants to ensure that the entity printing medical devices have the understanding and expertise to handle the process.

Submit comments on the discussion paper

The discussion paper goes on to ask specific questions from the industry, manufacturers, healthcare providers, and other stakeholders to address the challenges and concerns of 3D printed medical devices. Comments are open until February 8, 2022.