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FDA境外器械GCP规定正式生效

发布时间:2019-03-12 浏览次数:1605

美国FDA对医疗器械境外临床试验需符合GCP的最终要求于2019年2月21日正式生效。

这项2018年颁布的最终规定的目的,是确保医疗器械的临床试验产生的数据能够与FDA要求相一致,无论哪种上市申报或申请类型,也无论临床试验在美国境内还是在境外开展。

就在一年前,该规定提出一项要求,在美国境外进行医疗器械临床试验的申请人应提供GCP符合性声明,同时也修订了在美国进行临床试验的某些提交和申请方面的法规,即与人体受试者保护、伦理审查委员会、研究用器械豁免政策(IDE)申请相关的法规方面要求提供一项符合性声明,其范围包括IDEs、510(k)提交、人道主义器械的豁免(HDE)申请。对于国外临床试验的要求也适用于上市前批准申请(PMAs),de novo 分类请求和产品开发方案。

为有助于申请者遵守最新要求,FDA的器械和辐射安全中心(CDRH)发布了一项关于支持申请和提交可接受的临床数据指南。去年二月该指南和上述最终规定同时发布。

在21日一份发给企业的提醒生效日期的公告中,CDRH提出,该项最终规定适用于2019年2月21日及以后完成入组第一例患者工作的所有临床试验,适用于IDEs,510(k),de novo,PMAs,HDEs或产品开发方案。

CDRH也介绍了一个新网站,助力最终规定、指南和拒绝接受(RTA)政策的合规性。这一项关于510(k)提交和PMA申请的RTA政策指南于去年一月份进行了更新。

Final FDA Rule toRequire Foreign Device GCP Compliance Comes into Effect

Posted 21 February2019 | By Ana Mulero 

The US Food andDrug Administration (FDA) final rule that requires foreign clinical investigationsfor medical devices to comply with good clinical practice (GCP)requirementscame into effect on Thursday.  

 The 2018 final rule is intended to provideconsistency in the agency requirements for the acceptance of data derived frommedical device clinical investigation, regardless of the type of marketingsubmission or application and whether the investigation was conducted in oroutside of the US.
Exactly one year ago, the final rule set a requirement for sponsorsand applicants conducting medical device investigations overseas to provide astatement of GCP compliance. It also amended regulations on certain submissionsand applications for US investigations to require a statement of compliancewith set regulations in the areas of human subject protection, institutionalreview boards and investigational device exemption (IDE) applications. Theseinclude IDEs, 510(k)submissions and humanitarian device exemption (HDE) applications.The requirement on foreign investigations also applies to premarket approval applications(PMAs), de novo classification requests and product development protocols.

 To help sponsors and applicants comply withthe new and updated requirements, FDA Center for Devices and RadiologicalHealth (CDRH) issued guidance on the acceptance of clinical data to supportapplications and submissions. This was issued along with the releaseof the final rule last February.

 In a notice sent on Thursday to remind industryof the effective date, CDRH noted that the final rule applies to all clinicalinvestigations that enroll the first subject on or after 21 February 2019 andthat support IDEs, 510(k)s, de novo, PMAs, HDEs or product developmentprotocols.

 CDRH also pointed to anew webpage aimed at aiding in compliance with the requirements ofthe final rule and final guidance on refuse-to-accept (RTA)policies thatreceived minor updates to reflect these requirements. The guidance on RTApolicies for 510(k) submissions and PMA application was updated lastJanuary.

博尼尔专注的业务范围:

1、ISO13485医疗器械质量管理体系咨询辅导;

2、MD GMP医疗器械良好生产实践咨询辅导; 

3、ISO22716化妆品GMP管理体系咨询辅导;

4、MDSAP医疗器械单一审核程序认证咨询辅导;

5、美国FDA QSR820法规体系咨询辅导、协助FDA验厂服务;      

6、医疗器械全球注册服务,包括美国510k注册, 欧盟CE注册, 加拿大MDL注册及中国CFDA注册等;

7、医疗器械上市后法规符合性服务,如医疗器械不良事件管理、医疗器械上市后跟踪服务等;

8、医疗器械法规与质量工具的培训,包括MDSAP法规、CAPA系统、验证&确认、风险管理等;

9、医疗器械中国代理人(MD delegate in China)服务为海外医疗器械生产企业提供ⅠⅡⅢ类医疗器械在中国的注册及法规符合性服务。

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