I had the good fortune to be able to participate in delivery of reviewer training to the CFDA’s Center for Medical Device Evaluation in Beijing last month. This training was put together by a number of Senior members of the ISO TC 194 committee which develops the ISO 10993 group of standards. The experts were in China to participate in the Biocompatibility Workshop of the CIMDR conference and took the opportunity to run the CMDE training as a satellite event.
CMDE has been open to risk based submissions for biological evaluation for some time now with previous participation in Workshops and CMDE training events to strengthen their technical capacity in this area. This year was a real step up. More than 100 reviewers attended from all review divisions of CMDE – including a large number of new hires. The course covered the overall risk management model embodied within ISO 10993, the forthcoming revision to Part 1 standard, as well as some deep dives and cases studies in areas including chemical characterisation in support of biological evaluation, and application of concepts such as thresholds of toxicological concern.
There was very lively Q&A, with some thoughtful insights into how to tackle biological evaluation. ISO 10993-1 has always had a risk management model, and successive revisions of the standard have increased the emphasis on that approach. It’s not just about doing the tests and checking the boxes, but requires a much more holistic approach including better understanding of device materials and composition and overall risk assessment and expert review. Regulators have often been criticised for taking too conservative an approach and relying on a rigid requirement for testing.
So the plea from CMDE during this workshop was surprising. “Yes” they said… “we understand and support a risk managed approach and are able to accept risk based submissions – but the industry keeps sending us files which are just compilations of test reports.” So – there you have it – CMDE have built it – will you come?
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