AdvaMed called for Health Canada to revise and clarify its draft guidance on licensing requirements for implantable devices made through 3D printing.
Specifically, the association called for the agency to add clarifications and new information to the guidance, such as a revision to align the guidance with the agency’s license applications guidance and to clarify the different expectations for Class III and IV devices.
“The license applications guidance asks for significantly less information on manufacturing and quality controls for Class III devices,” AdvaMed said. “It is unclear in the 3D printing guidance if this expectation carries through to 3D-printed devices, or if there are higher expectations for Class III 3D-printed devices.”
To address the uncertainty, the agency should clarify what it expects in an application versus what would be more appropriate for review during quality management system audits, AdvaMed said. The group also asked Health Canada to note when the information is in addition to the license applications guidance or when it is intended to clarify specific 3D-printed device expectations.
The trade group also urged the agency to replace the phrase “patient specific” with “patient matched” throughout the guidance, in order to align with the International Medical Regulators Forum (IMDRF)’s definitions for personalized medical devices and move closer to reaching a harmonized regulatory pathway for 3D-printed devices. “Patient-matched” is more descriptive of 3D-printed devices, the group said, because “patient specific” could be misunderstood as meaning “custom-made.”
It also called for a restructuring of the document to better illustrate the manufacturing process flow of 3D-printed devices. 3D Printing is a manufacturing process — additive manufacturing — and manufacturers will follow design control and product realization processes, the group said. “The structure and flow of the guidance does not always follow this process and we believe it would be helpful to restructure the document accordingly.”
Health Canada is represented on the IMDRF personalized devices working group and is currently participating in IMDRF’s international harmonization effort.
Read AdvaMed’s recommendations here: www.fdanews.com/01-17-19-Advamed.pdf. — James Miessler