The FDA recently held a webinar to discuss the creation of new guidance and product liability guidelines in relation to 3-D printing and digital manufacturing.
Mark C. Levy, Esq., partner at Eckert Seamans Cherin and Mellott LLC, and Richard Underwood, PhD, CEng, manager of biomedical engineering at Exponent, led the discussion. They noted that while the FDA is able to identify similarities between 3-D printed devices and existing technologies, there are key differences in safety and effectiveness to be evaluated.
A “leapfrog” draft guidance titled “Technical Considerations for Additive Manufactured Devices” was issued on May 10, 2016 “to describe issues to be considered and addressed during product development and premarket submission,” according to materials for the webinar. These issues include the manufacturing and design process, software workflow, material controls, post-processing, process validation and acceptance, and quality data. The speakers noted these issues also include device description and testing, mechanical testing, material characterization, cleaning and sterilization, biocompatibility, additional labeling considerations for devices, product liability and insurance.
“[The] FDA-issued guidance is a unique piece [in] that when there is a new technology out there or new products [go] to market, [the] FDA has allowed itself to give interim guidance that is subject to change,” Levy said. “And with any guidance document, when it becomes final, [it] is of no binding authority on the agency or any of the constituents.”
He added, “So right now, we are in a period where the agency is trying to give advice, essentially a framework, for those who are already involved in the manufacturing and design process. That [includes] those that work with 3-D printing, those that manufacture the materials, medical device companies [and] the end user.”
According to the webinar, the International Organization for Standardization (ISO) and the American Society for Testing and Materials (ASTM) are developing joint additive manufacturing standards. The current standards cover terminology, device testing methods and manufacturing.
Future standards, the speakers noted, will cover design guides and specific requirements for purchased additive manufacturing parts.
In addition, there is an agreement in place with the ISO that could establish new standards applicable across many industries, processes and applications, as well as set specialized standards that address technology-specific topics. A total of 11 of ASTM standards have been established, according to materials from the webinar, and more than 20 are in progress.
The FDA Office of Science and Engineering Laboratories is investigating additive manufacturing medical devices, according to the speakers. The FDA is also launching the FDA Additive Manufacturing Working Group that will invite industry experts, academics and early adopter clinicians to address lingering uncertainties and other concerns related to 3-D printed medical products. A meeting is scheduled for October. – by Shawn M. Carter
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Disclosure: This content was derived from the FDAnews Webinar on FDA’s Office of Combination Products.
