It has been proposed to change the 2-dimensional shape of a class III bioabsorbable implant. There will only be one difference in the processing of the new implant versus the old one and that is that the material from which the cutting tool is made will change from Stainless Steel (D2) to Stainless Steel (410). The implant is in contact with the cutting edge for a matter of seconds. Based on a literature review the 400 series SS is frequently used in the manufacture of surgical drilling and cutting tools. The same cleaning materials would be used so there would be no risk of new residues from processing aids being introduced.
Given cost and time restraints, I'd like to get this communities thoughts on the following options for submission of the change notification to both US and EU regulators (under MDR)
Given cost and time restraints, I'd like to get this communities thoughts on the following options for submission of the change notification to both US and EU regulators (under MDR)
- Would the above justification be sufficient to address this change i.e. that the change does not introduce any new risks from a biocompatibility perspective because i) there is no change to the processing aids used ii) though the SS used is of a different grade, the grade used is in contact with the implant very briefly and iii) the 400 series SS is frequently used in the manufacture of surgical instruments e.g. dental drills? Based on this justification, it would be reasonable to say that no additional biocompatibility testing is required and the biocompatibility data from the original implant is sufficient to demonstrate the biological safety of the new implant?
- Would additional biocompatibility testing have to be performed to justify this process change and if so, what testing would be recommended?