Defending substantial equivalence: an argument for the continuing validity of the 510(k) premarket notification process.
作者信息
Flaherty James M
机构信息
Foley Hoag LLP, Boston, Massachusetts, USA.
出版信息
Food Drug Law J. 2008;63(4):901-27.
PMID:19601388
Abstract
摘要
相似文献
1
2
Medical devices; exemptions from premarket notification and reserved devices; class I--FDA. Notice.医疗器械；免于上市前通知和保留器械；I类——美国食品药品监督管理局。通知。
Fed Regist. 1998 Feb 2;63(21):5387-93.
3
4
5
6
The evolution of substantial equivalence in FDA's premarket review of medical devices.美国食品药品监督管理局医疗器械上市前审查中实质等同性的演变
Food Drug Law J. 2001;56(3):317-37.
7
Gastroenterology and urology devices; effective date of requirement for premarket approval of the implanted mechanical/hydraulic urinary continence device. Food and Drug Administration, HHS. Final rule.胃肠病学和泌尿学器械；植入式机械/液压尿失禁器械上市前批准要求的生效日期。美国卫生与公众服务部食品药品监督管理局。最终规则。
Fed Regist. 2000 Sep 26;65(187):57726-32.
8
Medical devices; exemption from premarket notification and reserved devices; Class I--FDA. Proposed rule.医疗器械；免于上市前通知和保留器械；I类——美国食品药品监督管理局。拟议规则。
Fed Regist. 1998 Nov 12;63(218):63222-53.
9
10
Express preemption and premarket approval under the Medical Device Amendments.《医疗器械修正案》下的快速预emption和上市前批准。
Food Drug Law J. 2004;59(2):245-64.
引用本文的文献
1
Advances in In Vitro and In Vivo Bioreactor-Based Bone Generation for Craniofacial Tissue Engineering.用于颅面组织工程的基于体外和体内生物反应器的骨生成研究进展
BME Front. 2023 Jan 31;4:0004. doi: 10.34133/bmef.0004. eCollection 2023.
2
Mapping the genealogy of medical device predicates in the United States.绘制美国医疗器械谓词的谱系图。
PLoS One. 2021 Oct 7;16(10):e0258153. doi: 10.1371/journal.pone.0258153. eCollection 2021.
3
Roadside Drug Testing Approaches.路边药物检测方法。
Molecules. 2021 May 29;26(11):3291. doi: 10.3390/molecules26113291.
Zotero 插件