美国FDA医疗器械创新审评机制研究

摘要/Abstract

摘要： 目的：解读美国FDA医疗器械审评机制，特别是创新审评审批的运行情况，为我国医疗器械监管提供参考。方法：阐述美国FDA监管政策的发展及应用情况，分析美国FDA与我国医疗器械创新监管上的异同。结果：美国FDA医疗器械监管创新措施能够保障监管决策的可靠性，促进创新的医疗器械进入市场，也有利于加强外部合作，实现资源利用最大化。结论：结合美国FDA医疗器械审评机制，优化我国监管体系，提高监管效率，加快创新产品的市场准入。

关键词: font-size:medium, ">创新医疗器械；监管政策；监管科学；美国食品药品管理局

Abstract: Objective： To interpret medical device review mechanism of the FDA， especially the operation of innovation review， and provide references for the improvement of medical device regulation in China. Methods： Elaborate on the development and application of regulatory policies by the FDA， and analyze the similarities and differences between the FDA and China's medical device innovation regulation. Results： Innovative measures in US medical device regulation can ensure the reliability of regulatory decisions， promote the entry of innovative medical devices into the market， strengthen external cooperation， and maximize resource utilization. Conclusion： Combining the FDA medical device review mechanism， optimizing the domestic regulatory system， improving regulatory efficiency， and accelerating market access for innovative products.

Key words: font-size:medium, ">Innovative medical device； Regulatory policies； Regulatory science；Innovation review；U.S.Food and Drug Administration（FDA）

中图分类号:

彭谱1, 朱传清1, 朱鹏志1, 张世庆2, 仉琪2. 美国FDA医疗器械创新审评机制研究[J]. 中国药物评价, 2024, 41(5): 337-345.

PENG Pu1, ZHU Chuan-qing1, ZHU Peng-zhi1, ZHANG Shi-qing2, ZHANG Qi2. Research on the FDA Innovation Review Mechanism of Medical Devices[J]. CHINESE JOURNAL OF DRUG EVALUATION, 2024, 41(5): 337-345.

参考文献

[1] 张世庆，邓洁，章金刚.美国医疗器械监管模式概述[J].中国医疗器械信息， 2009， 15(10):6.
     [2] 沈翀.美国FDA医疗器械和放射健康中心(CDRH)医疗器械监管模式概述[J].中国医疗设备， 2010，3:3.
     [3] U.S. Food and Drug Administration. 2024 CDRH Innovation Report [EB/OL].（2024-04-17) [2024-08-27]. https://www.fda.gov/media/177865/download.
     [4] 杨悦.美国药品监管科学研究[M].北京：中国医药科技出版社，2020.
     [5] U.S. Food and Drug Administration. Breakthrough Devices Program [EB/OL].（2024-08-09) [2024-08-27]. https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program.
     [6] 仉琪，姜雨萌，李耀华. 美国FDA突破性器械项目政策介绍及对我国的启示[J].中国医疗器械信息，2020，26(1): 1-3.
     [7] U.S. Food and Drug Administration. Safer Technologies Program（SteP) for Medical Devices [EB/OL].（2021-03-15) [2024-08-27]. https://www.fda.gov/medical-devices/how-study-and-market-your-device/safer-technologies-program-step-medical-devices.
     [8] U.S. Food and Drug Administration. Total Product Life Cycle Advisory Program（TAP) [EB/OL].（2024-08-12) [2024-08-27]. https://www.fda.gov/medical-devices/how-study-and-market-your-device/total-product-life-cycle-advisory-program-tap.
     [9] U.S. Food and Drug Administration. Medical Device User Fee Amendments 2022（MDUFA V) [EB/OL].（2023-08-22) [2024-08-27]. https://www.fda.gov/industry/medical-device-user-fee-amendments-mdufa/medical-device-user-fee-amendments-2022-mdufa-v.
     [10] U.S. Food and Drug Administration. CFR-Code of Federal Regulations Title 21（fda.gov) [EB/OL].（2024-03-22) [2024-08-27]. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=860&showFR=1&subpartNode=21:8.0.1.1.16.4.
     [11] U.S. Food and Drug Administration. Acceptance Review for De Novo Classification Requests [EB/OL].（2021-10-05) [2024-08-27]. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/acceptance-review-de-novo-classification-requests.
     [12] U.S. Food and Drug Administration. De Novo Classification Process（Evaluation of Automatic Class III Designation) [EB/OL].（2021-10-05) [2024-08-27]. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/de-novo-classification-process-evaluation-automatic-class-iii-designation.
     [13] U.S. Food and Drug Administration. FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals [EB/OL].（2022-10-03) [2024-08-27]. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-and-industry-actions-de-novo-classification-requests-effect-fda-review-clock-and-goals.
     [14] U.S. Food and Drug Administration. Electronic Submission Template for Medical Device De Novo Requests [EB/OL].（2024-08-23) [2024.08-27]. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/electronic-submission-template-medical-device-de-novo-requests.
     [15] U.S. Food and Drug Administration. Medical Device User Fee Amendments（MDUFA) [EB/OL].（2024-08-01) [2024-08-27]. https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa.
     [16] 刘清峰，莫国民.中美创新医疗器械审批进展、差距及建议[J].上海医药， 2018， 39(13):4.
     [17] 塔娜，王涵，李耀华.中美对创新和临床急需医疗器械的审评审批途径简介与思考[J].中国药事， 2019，4:5.
     [18] U.S. Food and Drug Administration. CDRH 2021 Annual Report [EB/OL].（2022-01-31) [2024-08-27]. https://www.fda.gov/about-fda/cdrh-reports/cdrh-2021-annual-report.
     [19] U.S. Food and Drug Administration. CDRH 2021 Annual Report [EB/OL].（2023-01-26) [2024-08-27]. https://www.fda.gov/about-fda/cdrh-reports/cdrh-2022-annual-report.
     [20] U.S. Food and Drug Administration. CDRH 2023 Annual Report [EB/OL].（2024-01-17) [2024-08-27]. https://www.fda.gov/about-fda/cdrh-reports/cdrh-2023-annual-report.
     [21] U.S. Food and Drug Administration. Digital Health Software Precertification（Pre-Cert) Pilot Program [EB/OL].（2022-09-26) [2024-08-27]. https://www.fda.gov/medical-devices/digital-health-center-excellence/digital-health-software-precertification-pre-cert-pilot-program.
     [22] 陈雪莹，李杨玲，杨雨曼，等.国际医疗器械监管模式的对比分析与启示[J].中国医药工业杂志，2023，54(3):446-454.