Mandatory Post-Market Studies of Medical Devices

doi:10.19803/j.1672-8629.20250617

Abstract

Abstract: Objective To find out about the implementation of the Post-Approval Studies (PAS) and Section 522 Postmarket Surveillance Studies programs, and to provide insights into the regulatory framework of China's counterparts. Methods A cross-sectional analysis was conducted. Data from the FDA’s official PAS and 522 study databases was analyzed. The basic characteristics, study designs, programs completed, and applications of findings were compared between the two systems. The findings were then analyzed in light of the current regulatory landscape in China. Results A total of 970 PAS (1991-2025) and 409 522 Studies (2001-2025) were included. The PAS primarily targeted Class Ⅲ high-risk devices approved via the Premarket Approval (PMA) pathway (93.3%). The study designs were predominantly prospective cohorts (65.05%), demonstrating a relatively high rate of completion (57.73%). In contrast, the 522 studies involved Class Ⅱ devices cleared via the 510(k) pathway (92.9%). Their design was primarily cross-sectional (21.03%), with a low rate of completion (12.47%). Findings from both programs were effectively used for label updates and regulatory decision-making, yet challenges like high costs, delayed reactions, and insufficient transparency of data persisted. Conclusion It is recommended that China, within its existing regulatory framework, continue to refine and elaborate its mandatory postmarket study regulations based on practical oversight experience in order to facilitate execution control and the transformation of research findings.

Key words: Medical Devices, Postmarket Studies, Post-Approval Study (PAS), Section 522 Postmarket Surveillance Studies, FDA, Regulatory Science

CLC Number:

R951

LI Dong, ZHANG Longying, SHEN Xiaohua, LIU Zhangpin, WU Zhengshan, ZHAO Yan. Mandatory Post-Market Studies of Medical Devices[J]. Chinese Journal of Pharmacovigilance, 2025, 22(12): 1383-1387.

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https://zgywjj.magtechjournal.com/EN/Y2025/V22/I12/1383

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