骨科器械；髋关节金属/聚合物或陶瓷/聚合物半限制型表面置换骨水泥型假体上市前批准要求的有效数据。最终规则。

Orthopedic devices; effective data of requirement for premarket approval for hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis. Final rule.

出版信息

Fed Regist. 2004 Oct 4;69(191):59132-4.

Abstract

The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis. The agency also is summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the devices to meet the statute's approval requirements and the benefits to the public from the use of the devices. This action implements certain statutory requirements.

摘要

美国食品药品监督管理局（FDA）正在发布一项最终规则，要求为髋关节金属/聚合物或陶瓷/聚合物半约束型表面置换骨水泥假体提交上市前批准申请（PMA）或产品开发方案完成通知（PDP）。该机构还在总结其关于通过要求这些器械符合法规的批准要求来消除或降低的疾病或伤害风险程度的拟议调查结果，以及使用这些器械给公众带来的益处。此行动落实了某些法定要求。

相似文献

1

Orthopedic devices; effective data of requirement for premarket approval for hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis. Final rule.骨科器械；髋关节金属/聚合物或陶瓷/聚合物半限制型表面置换骨水泥型假体上市前批准要求的有效数据。最终规则。

Fed Regist. 2004 Oct 4;69(191):59132-4.

2

Obstetric and gynecology devices; effective date of requirement for premarket approval for glans sheath devices. Final rule.妇产科器械；龟头套装置上市前批准要求的生效日期。最终规则。

Fed Regist. 2002 Jun 14;67(115):40848-9.

3

Medical devices; effective date of requirement for premarket approval for three preamendment class III devices. Food and Drug Administration, HHS. Final rule.医疗器械；三种修正案前III类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管理局。最终规则。

Fed Regist. 2000 Apr 13;65(72):19833-4.

4

Medical devices; effective date of requirement for premarket approval for three class III preamendments devices. Final rule.医疗器械；三类《修正案》前器械上市前批准要求的生效日期。最终规则。

Fed Regist. 2004 Jun 23;69(120):34917-20.

5

Effective date of requirement for premarket approval for three class III preamendments devices. Final rule.三类《修正案》前器械上市前批准要求的生效日期。最终规则。

Fed Regist. 2011 Aug 16;76(158):50663-7.

6

Medical devices; effective date of requirement for premarket approval for three class III preamendments devices--FDA. Proposed rule; opportunity to request a change in classification.

Fed Regist. 1998 Aug 18;63(159):44177-81.

7

Effective date of requirement for premarket approval for cardiovascular permanent pacemaker electrode. Final rule.心血管永久性起搏器电极上市前批准要求的生效日期。最终规则。

Fed Regist. 2012 Jul 6;77(130):39924-7.

8

Medical devices; effective date of requirement for premarket approval for a class III preamendments obstetrical and gynecological device. Food and Drug Administration, HHS. Final rule.

Fed Regist. 2000 Jul 5;65(129):41330-2.

9

Effective date of requirement for premarket approval for a pacemaker programmer. Final rule.起搏器程控仪上市前批准要求的生效日期。最终规则。

Fed Regist. 2012 Jun 22;77(121):37570-3.

10

Effective date of requirement for premarket approval for an implantable pacemaker pulse generator. Final rule.植入式起搏器脉冲发生器上市前批准要求的生效日期。最终规则。

Fed Regist. 2012 Jun 22;77(121):37575-6.

文献检索

告别复杂PubMed语法，用中文像聊天一样搜索，搜遍4000万医学文献。AI智能推荐，让科研检索更轻松。

立即免费搜索

文件翻译

保留排版，准确专业，支持PDF/Word/PPT等文件格式，支持 12+语言互译。

免费翻译文档

深度研究

AI帮你快速写综述，25分钟生成高质量综述，智能提取关键信息，辅助科研写作。

立即免费体验