척추 임플란트의 기계적 성능시험 및 허가 전략: ASTM 표준 기반 접근
Mechanical Performance Testing and Regulatory Strategy of Spinal Implants: Based on ASTM Standards
0
조회
0
다운로드
0
인용
0
참고문헌
키워드
초록
Spinal implants are medical devices that play a crucial role in restoring spinal stability and function in patients with degenerative or traumatic disorders. Because these implants are permanently placed within the human body, their mechanical performance and long-term reliability must be rigorously evaluated to ensure patient safety. However, despite the global adoption of ASTM International standards for mechanical testing, differences remain between national regulatory requirements, particularly between the Ministry of Food and Drug Safety (MFDS) in Korea and the U.S. Food and Drug Administration (FDA). These discrepancies often cause inconsistencies in test planning, model selection, and acceptance criteria during product registration. This study proposes a standardized regulatory framework for spinal implants based on ASTM standards, focusing on five key components: (1) applicable standards, (2) representative model selection, (3) establishment of acceptance criteria, (4) mechanical performance testing, and (5) management of test laboratories and equipment. By analyzing these elements within the context of both Korean and U.S. regulatory systems, the study provides a practical guideline for preparing Summary Technical Documentation (STED) and 510(k) submissions. The proposed framework enhances the consistency and traceability of mechanical test data, supports scientific justification for representative model selection, and improves comparability between domestic and international evaluations. This research serves as a reference for medical device manufacturers, helping them establish efficient verification systems that meet both MFDS and FDA requirements and promote global regulatory harmonization.
Abstract
Spinal implants are medical devices that play a crucial role in restoring spinal stability and function in patients with degenerative or traumatic disorders. Because these implants are permanently placed within the human body, their mechanical performance and long-term reliability must be rigorously evaluated to ensure patient safety. However, despite the global adoption of ASTM International standards for mechanical testing, differences remain between national regulatory requirements, particularly between the Ministry of Food and Drug Safety (MFDS) in Korea and the U.S. Food and Drug Administration (FDA). These discrepancies often cause inconsistencies in test planning, model selection, and acceptance criteria during product registration. This study proposes a standardized regulatory framework for spinal implants based on ASTM standards, focusing on five key components: (1) applicable standards, (2) representative model selection, (3) establishment of acceptance criteria, (4) mechanical performance testing, and (5) management of test laboratories and equipment. By analyzing these elements within the context of both Korean and U.S. regulatory systems, the study provides a practical guideline for preparing Summary Technical Documentation (STED) and 510(k) submissions. The proposed framework enhances the consistency and traceability of mechanical test data, supports scientific justification for representative model selection, and improves comparability between domestic and international evaluations. This research serves as a reference for medical device manufacturers, helping them establish efficient verification systems that meet both MFDS and FDA requirements and promote global regulatory harmonization.