FDA Grapples with Future Regulation of 3-D Printed Medical Devices, by Shana Leonard on June 13, 2014; Medical Device & Diagnostic Industry.
"As the concepts of patient matching and on-demand 3-D printing of medical devices in healthcare facilities inch closer to reality, FDA tries
–to determine its role and [it will presume authority by the Food, Drug & Cosmetics Act]
–how to regulate products produced using additive manufacturing."
Steven K. Pollack, director of the Office of Science & Engineering Labs at FDA, said during a presentation at MD&M East, commented-
“Right now, the devices that we’ve seen coming through the pipeline with additive manufacturing really don’t raise for us any major red flags that say additive manufacturing is a new problem that we have to think about very differently,” Pollack said. “But we’re out there really trying to address what this technology brings to us.”
"In particular, the agency identifies
–mechanical properties
–biocompatibility and
–interactive design
as areas of additive manufacturing that it’s keeping an eye on.
Mechanical testing [of tissue biostructure such as heart valves, fluid vessels, joints, and the like] questions may arise with medical devices produced using additive manufacturing, for instance, that wouldn’t with conventional manufacturing methods, Pollack said. The same goes for #biocompatibility ."
But as more complex devices are developed and 3-D printing allows for on-demand patient matching or customization, the most pressing issue for FDA centers on engineering versus clinical decisions, according to Pollack. ‘Where is the point where the machine building the device becomes an extension of the clinician?’"
"But it’s imperative to ensure that 3-D printed medical devices [organs, vascularization, #biostructures] are safe and effective—regardless of where they’re manufactured, Pollack stressed. Ultimately, he noted, these on-site-printed devices would need to be reproducible and have a valid design; quality control processes will also need to be in place for the manufacture of the product.
[Mr. Pollack is referring to the FDA Quality System, an over-arching regulation of design, production, quality assurance and “safe and effective” measures. Analyzing 21 CFR Part 820 Quality System Regulation will have essential inputs for getting FDA clearance to market your #bioprints .]
"FDA has created an additive manufacturing working group to
–explore some of these issues
–ensure consistency across the agency and
–develop policy for the regulation of the field."
"However, Pollack noted that FDA is actively seeking assistance from industry and academia to identify potential technological challenges and solutions for producing novel medical devices using 3-D printing.
“The agency will hold an additive manufacturing workshop and Webinar in October with this purpose that will help shape a future technical guidance” [for complying with FDA regulations when they are made law].
#fdaregulation #additivemanufacturing #21CFRPart820 #3dprinting
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