|Oxford Performance Materials's OsteoFab Patient-Specific Facial Device is one of 85 3-D printed medical devices that have been approved or cleared by FDA so far.|
Medical device manufacturers that have been hesitant to move forward with 3-D printing due to regulatory uncertainty seemingly got a green light today from the director of CDRH’s applied research arm.
Steven K. Pollack, director of the Office of Science and Engineering Laboratories, told an audience today at MD&M West that FDA isn’t as perplexed by additive manufacturing as many have feared.
“The overarching view is that it’s a manufacturing technology, not something that exotic from what we’ve seen before,” he said, adding that the agency views 3-D printing as an enabling technology similar to other advanced manufacturing methods, such as CNC machining.
As such, FDA doesn’t see the need to pile on new regulations to address 3-d printing.
“The current perspective is that it’s not something we’re unprepared for with the current paradigm we have for regulation,” Pollack said.
However, a pair of guidances on the topic of 3-D printing are in the works. For one that will cover the agency’s thinking on who the manufacturer is and where manufacture occurs when 3-D printing is used, Pollack provided no estimated time of arrival, saying only, “It’s complicated.” But guidance on what questions manufacturers of 3-D printed medical devices can expect from FDA will come out this year, he said.
So far, issues that tend to come up with 3-D printed devices include the following:
- How do you clean it?
- How do you remove the processing agents form the final product?
- How do you ensure biocompatibility?
But, as Pollack said, “they’re not showstoppers, just questions.”
And if you’re unwilling to take the agency at its word, consider the experience of Stryker, which has received 510(k) clearance for two orthopedic implants made using 3-D printing. Naomi Murray, the company’s senior manager of additive manufacturing, told an MD&M West audience that although the company faced questions from FDA with regard to its additive manufacturing processing and testing, it “wasn’t overwhelming.”
FDA has so far approved 85 medical devices made using 3-D printing, most of them via the 510(k) or emergency use pathways, according to Pollack. “They’re not something brand new and special,” he said, citing examples including spinal cages, dental restorative devices, and hearing aids with 3-D printed components.
“We’re still waiting for devices that we haven’t been able to make before, and that’s when we’re going to see the PMAs,” Pollack said.
So what’s the holdup? Pollack said he believes companies are waiting for someone else to test the waters, but from FDA’s perspective, it’s time for the industry to dive in.