| Objective To explore technical concerns during pre-market registration evaluation on individualized anatomy-matching bone prosthesis (IAMP, generalized customization), which are different from regular bone implants with committed parameters on types and specification. Also to subdivide the concept on customization, and to explore requirement on post-market study corresponding to conclusion of evaluation. Methods Based on expert panel consultation and primary supplement, CMDE reviewers conducted technical review and required additional research on characterized customized craniomaxillofacial reconstructive implant; based on close communication with CMDE reviewer, R&D group and clinical investigators supplemented clinical validation on design & development according to product design specification. Due to the inherent defect on opened, single group, non-randomized, self-controlled longitudinal case series, the investigators collected the retrospective study on equivalent patient population of reconstructive plates, to form historical case-control study; based on the clinical significance of above contrastive study, the reviewers assessed on-market risk, and cooperated with manufacture to form detailed post-market study requirement. Results Distinguished from registration product standard of regular committed medical devices, reviewer enhanced qualitative design specification with design boundary; based on priori information of pre-market D&D verification and validation, the reviewer concluded advanced requirement on post-market clinical/non-clinical study which complemented with the manufacture’s post market study plan, including accumulation of product design parameters and performance data, and statistical summary of clinical follow-up data. Conclusions Based on that the clinical validation is different from regular implants with committed parameters on types and specification, the risk control of IAMP should combine pre and post market clinical study data to integrate appraisal on risk tendency. So that the D&D circle from individual customization to batch-produced standardized product can be properly accelerated, and we hope the overtaking corners for original design and development of domestic medical device can be assisted. |
