The FDA’s draft guidance on 3-D printing, or additive manufacturing of medical devices, needs a fair amount of work, according to 23 comments received by the agency.
The draft guidance — which builds on discussions from an October 2014 workshop on AM —is what the agency calls a “leap-frog guidance,” aimed to provide the agency’s initial perspective on emerging technologies ().
The Medical Imaging and Technology Alliance, said that although the FDA acknowledged that additive manufacturing is bringing rapid change to the medical device industry, the agency needs to consider how it would coordinate printing with medical imaging.
How to Ensure Calibration
For example, the agency acknowledged in the draft guidance that AM has the potential to create anatomically matched medical devices and surgical implementation based on an individual patient’s medical imaging, but the agency has not considered how it would ensure that devices used for AM are properly calibrated and that the images from which they are copied provide sufficient detail for accurate reproduction, MITA said.
In addition, the agency needs to consider how it would treat the software that will translate a medical image into a file that can be applied by a 3D printer.
MITA also noted that the guidance does not apply to devices that involve bioprinting or point-of-care manufacturing, which “further complicate the regulation of AM.”
Community Based Personalized Healthcare, based in Victoria, Australia, said that the FDA “needs to realize that a complete paradigm shift is required to truly regulate the quality and cost effectiveness of medical devices and products in the future.”
The association noted that additive manufacturing would actually reduce risk to patients because the greater risk is the current “off-the-shelf medical device industry,” which affects thousands of patients over a period of many years.
“Now patient-specific designs can be continually improved by way of iteration in a quality process that is impossible with mass manufacture,” the association said, adding that “a regulated process can create reimbursable devices using distributed community-based manufacturing.”