医疗器械的管理可以从药品管理中吸取经验教训

Regulation of devices Lessons can be learnt from drug regulation

导出

摘要医疗器械的研发、批准上市和监管与处方药在某些方面有相似之处，同时更具有挑战性。然而，器械管理的传统和药品大不相同，存在问题更多。例如，Lenzer和Brownlee（doi：10．1136／bmj．c4753）报道了一种治疗癫痫的交感神经刺激器。

作者 Jerry Avorn 付晓霞(译)

机构地区 Department of Medicine 中华儿科杂志编辑部

出处《英国医学杂志中文版》 2011年第2期70-72,共3页 The BMJ Chinese Edition

关键词药品管理医疗器械吸取神经刺激器批准上市器械管理处方药 BMJ

参考文献5

1Lenzer J, Brownlee S. Why the FDA can't protect the public. BMJ 2010; 341:10.1136/bmj. c4753.
2Maisel WH. Medical device regulation: an introduction for the practicing physician. Ann Intern Med 2004 ; 140:296-302.
3Advanced Medical Technology Association. New study highlights safety of FDA's 510 (k) review process. 2010. www. advamed, org/MemberPortal/ About/NewsRoom/NewsReleases/PR-FDA510-91510. htm.
4Dhruva SS, Bero LA, Redberg RF. Strength of study evidence examined by the FDA in premarket approval of cardiovascular devices. JAMA 2009;302: 2679-85.
5Mass Device. Boston Scientific, Abbott, Johnson & Johnson embroiled in off- label stents case. 2010. www. massdevice, corn/node/5486.

英国医学杂志中文版

2011年第2期

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