While FDA made a push last fall to explore the technical challenges associated with 3-D printed devices (holding a public workshop in October 2014), the Agency's planned guidance on the topic fell to the "B-list" in FDA's 2015 medical device guidance agenda. According to the agenda, the Agency will issue a draft guidance document on 3-D printing as "guidance-development resources permit." In light of the regulatory uncertainty facing 3-D printing stakeholders, this may seem like unwelcome news – but is it?
Recent comments from Agency officials suggest that immediate guidance is unnecessary because 3-D printing, despite prior comments, is "business as usual" regulatory review work for FDA that might not need extensive specialized guidance. At a conference last month, the director of FDA's Office of Science and Engineering Laboratories, Steven Pollack, explained that the Agency generally sees 3-D printing as a manufacturing technology, "not something that exotic from what [its] seen before." Pollack also expressed that the Agency does not feel particularly unprepared to review 3-D printed devices under its current regulatory paradigm.
Still, during a January interview, Pollack did acknowledge that there are some unique challenges that 3-D printing may present for FDA and device manufacturers. For example, he expects that 3-D printed devices may require additional or different testing than is usually done. To minimize regulatory challenges, Pollack recommends that manufacturers looking to market 3-D printed devices participate in pre-submission meetings with FDA review teams. Such meetings can help FDA reviewers get a better understanding of the technology involved in manufacturing the device, which is critical. However, pre-submissions are, essentially, case-by-case and fact-specific negotiations. The process, though invaluable, also has some inherent inefficiencies and potential for inconsistencies that Agency-wider guidance can ameliorate.
3-D printing regulatory challenges may also be compounded by difficulties faced by manufacturers earlier in the design and development process. Dr. Scott Hollister, University of Michigan biomedical engineering professor and developer of a 3-D printed tracheal splint, has identified specific material-related challenges. In an article for PlasticsToday, Hollister cited the following as key issues related to 3-D printing materials: particle size (impacts the laser sintering process), the availability of materials, heat resistance, strength, and degradation rate.
So for now, FDA seems intent to function without specific regulatory guidance. While this may be a way to bring some advances to market, it seems like there are still regulatory challenges and uncertainties to address, which will likely only multiply as 3-D printed devices are developed for a greater variety of (and more complicated) uses. Therefore, the more guidance and transparency FDA can provide to stakeholders, the better. Considering FDA's 2015 guidance priorities, however, manufacturers hoping for specific regulatory clarity in this space likely will have a while to wait.
- Member of the Firm