A new leapfrog guidance from FDA gives a glimpse into the agency's thinking on 3-D printed medical devices.
Matthew R. Jorgensen, PhD
On May 10, 2016, FDA released a leapfrog guidance document on the technical considerations for additive manufactured or 3-D printed devices. Leapfrog guidance documents provide valuable information on what is in the regulatory pipeline and allow interested parties to have a voice in the development of FDA guidance.
Here are some key points from the draft guidance pertaining to the testing of medical devices.
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1.) During the 3-D printing process, the starting material may undergo significant chemical changes. Naturally, the starting material can have a significant impact on the properties of the final device. Information about the starting materials, including the following, should be documented:
- Material CAS number.
- Material specifications and certificates of analysis.
- Any processing aids, additives, and crosslinkers used.
2.) For additive manufacturing processes that utilize photopolymers, the percent crosslinking and degree of curing should be evaluated.
3.) All postprinting steps should be documented, considering the possible effects that these processes could have on the final device. While certain procedures can provide a desired surface finish, hard-to-reach internal areas may remain as-built.
4.) It is expected that the complex geometries of 3-D printed devices will increase the difficulty of cleaning and sterilization. There is an elevated risk of residual starting material and support materials remaining on the finished device, so destructive testing may be necessary to properly validate the cleaning method.
Three-dimensional printing has allowed the rapid creation of devices customized to individual patient anatomy based on radiological measurements. Certain complex device geometries are otherwise inaccessible outside of additive manufacturing. Appropriate testing of these devices considering their unique features is essential to protect patient safety and ensure the continued fruitful application of burgeoning technologies to medical device manufacturing.
Matthew R. Jorgensen, PhD, is a physical chemist and materials scientist at Nelson Laboratories LLC.
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