The FDA this week issued draft guidance intended to ensure the safe and reliable use of 3D printing for medical devices, a 25-page document that covers everything from design and manufacturing to testing and quality.
Regulators issued the document on May 10 and are soliciting comments and suggestions over the next 90 days. Interested parties can do so at http://www.regulations.gov.
Also known as additive manufacturing, 3D printing lets manufacturers rapidly alter designs without retooling, enabling the creation of a custom device or medical implant. The technology can also give doctors an additional tool through which to handle complex medical procedures. British scientists in 2014, for example, used the technology to make replica models of cancerous sections of the body that enabled doctors to target tumors more precisely.
The FDA said it wanted to outline “technical considerations” involved with 3D printing, and also issue recommendations to test and properly frame/market a medical device that’s made with at least one 3D step.
Once approved, manufacturers could use the guidelines to fulfill quality system requirements in order to submit a premarket approval application, pursue a humanitarian device exemption or make a 510(k) submission. The issue gets more complicated than that, however, if 3D printing is applied to biological, cellular or tissue-based products. The FDA said questions in this area would be referred to the Center for Biologics Evaluation & Research.
Much of the guidance looks to establish procedures used for more traditional manufacturing to ensure that a device with 3D components performs as intended. Such processes would theoretically be in place for Class II and III devices, and some Class I devices that rely on 3D components, measures that control design and manufacturing in a way that enables a consistent end result.
Apart from this, the FDA said in the draft guidance that manufacturers must clearly identify each step in the 3D printing process. Repetition will also be key, regulators said in their proposed guidelines.
“Quantitative knowledge of the machine’s capabilities and limitations can be gained through test builds, worst-case builds, or process validation,” the FDA said.
The draft guidance noted that traditional manufacturing relies on design requirements in order to produce a consistent product. The same holds true for 3D printing for medical devices.
“It is therefore important to clearly identify key design parameters for your device, including, but not limited to, size range and available design or configuration options,” the draft guidance states.
