510 (k) 第三方审查计划:承诺和潜力
Brian J Miller1,2,3, William Blanks4, Brian Yagi5
1Division of Hospital Medicine, Department of Medicine, The Johns Hopkins University School of Medicine, 600 N. Wolfe Street, Meyer 8-143, Baltimore, MD, 21287, USA. brian@brianjmillermd.com.
Journal of medical systems
|August 29, 2023
概括
美国食品和药物管理局 (FDA) 510(k) 途径每年审查数千种医疗器械. 本文探讨了第三方审查计划.
科学领域:
- 医疗器械监管法规 医疗器械监管法规
- 监管事务 监管事务
- 卫生政策 卫生政策
背景情况:
- 美国食品和药物管理局 (FDA) 510(k) 途径批准了几乎所有医疗器械,包括那些具有人工智能和ML等先进技术的医疗器械.
- 设备应用的复杂性和数量不断增加,需要有效的审查流程.
研究的目的:
- 审查FDA医疗器械监管的历史和演变以及510 (k) 路径.
- 分析510 (k) 第三方审查计划的历史和有效性.
- 解决利益相关者的担忧,并为第三方审查计划和FDA整体设备监管提出政策改进建议.
主要方法:
- 美国食品和药物管理局 (FDA) 设备监管和510(k) 途径的历史审查.
- 分析510 (k) 第三方审查计划的发展和功能.
- 审查包括FDA在内的利益相关方的政策关切和建议.
主要成果:
- 510 (k) 路径是医疗器械批准的主要路径,处理 99% 的设备.
- 25多年来,第三方组织一直在协助审查特定设备类别.
- 越来越复杂的设备,包括AI和ML,压力目前的审查能力.
结论:
- 简化对低至中等风险设备的审查可以提高FDA应对复杂监管挑战的能力.
- 改善第三方审查程序对于有效的FDA医疗器械监管至关重要.
- 政策调整是必要的,以优化第三方审查计划,并支持未来的监管需求.
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