AdvaMed is asking Health Canada to revise its draft guidance on preparing license applications for implantable medical devices that are produced using additive manufacturing or 3D printing.
The group argued for the several revisions outlined in its comment
to Health Canada—submitted on Tuesday—to “better reflect the manufacturing process flow,” avoid confusion around use of the term “validation” and address the emerging trend of point-of-care 3D printing.
Revisions are also needed to ensure consistency with the final version of a document developed by the International Medical Device Regulators Forum (IMDRF) on harmonized definitions for personalized devices. This is because Health Canada issued
its draft guidance on 3D-printing implantable devices shortly after the IMDRF document was finalized
in November 2018.
The IMDRF final document largely favored using the term “patient-matched” versus the draft version’s use of “patient-specific” devices. The change was necessary “as ‘patient-specific’ could be misconstrued as ‘custom-made,’ whereas ‘patient-matched’ is more descriptive of the devices in this category,” said AdvaMed associate vice president of technology and regulatory affairs Jamie Wolszon. Yet this change was not reflected in Health Canada’s draft guidance, despite being among the IMDRF member agencies.
The draft guidance does seek to harmonize Health Canada’s new policies by adopting the IMDRF definitions for personalized devices, but it refers to the proposed document from March 2018. It uses both the terms “patient-specific” and “patient-matched” interchangeably, which could in turn cause confusion.
“Given the ever-growing prevalence of 3D techniques in global manufacturing of medical devices, we appreciate Health Canada’s work on this issue both inside and outside of Canada,” Wolszon added. “We hope that our comments can help inform Health Canada’s current thinking, both as it relates to its own regulatory regime and as it participates in the harmonization effort with its fellow regulators at IMDRF.”
The terminology around 3D-printing is just one of the challenges IMDRF regulators have sought to address as it is still a relatively new manufacturing technique in the medical device space.
Wolszon pointed to Australia’s Therapeutic Goods Administration as one of the regulators “working to address the public health concerns related to rapid increase of 3D printer installation and manufacture of medical devices in hospital facilities, with little to no oversight.” The US Food and Drug Administration recently began targeting
hospitals’ 3D-printing as a new work area as well. In the Canada context, Wolszon said that AdvaMed is “concerned that this activity is not covered either by the licensing of class III and IV medical devices or the Special Access Program and could become exploited as an unregulated path to medical device manufacturing in a manner that compromises patient safety and public health.”
Other recommendations made by AdvaMed include improved alignment with 2012 guidance
on license applications for class III and class IV medical devices, clarifications around whether there should be additional considerations for those that are 3D-printed and adding policies to the guidance that would enable leverage of biocompatibility test information from previously licensed 3D-printed devices.