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【奥译言】FDA正式发布MDDT资格认证指南

阅读: 2017年08月15日

【奥译言】FDA正式发布MDDT资格认证指南

8月10日,美国食品药品管理局(FDA)正式发布了“医疗器械开发工具(MDDT)的资格认证”指南的终稿。

【摘要】

FDA宣布“医疗器械开发工具(MDDT)的资格认证”指南正式生效。其正式发布意味着MDDT程序的正式化。该指南为FDA工作人员、工厂、医务人员、研究者,以及患者和消费者提供了关于医疗器械开发工具的自愿认证路径。另外,该指南讨论了MDDT的框架,包括术语的定义、用于特定范畴MDDT的评估标准、有关资格认证的考虑,以及资格认证所需递交的资料。FDA已综合考虑公众对指南草案的意见,对该指南进行了适当的修改。

【正文】

MDDT是指用于帮助医疗器械开发和法规评估、已通过科学验证的工具。该指南描述了FDA器械和放射健康中心(CDRHMDDT自愿认证程序的框架和过程,包括术语的定义、用于特定范畴MDDT的评估标准、资格认证的最低要求,以及资格认证所需递交的资料。

 

该自愿认证程序的目的是:

1)使得用于挽救生命和有助健康的重要医疗器械能够更快、更有效地得到开发;

2)促进医疗器械开发工具的发展,以建立更及时的医疗器械评估;

3)提供更有影响力的监管机制;

4)关于促进医疗器械开发和法规评估的重要进展,能与CDRH利益相关者达到更快、更清晰的沟通。

 

CDRH希翼该资格认证程序能加快公开可用工具的发展,该类工具能广泛用于各种医疗器械研发过程。

 

该自愿认证程序的目的在于,促进医疗器械的开发和评估过程简化工具的发展和使用。一旦某项MDDT根据FDA预提交程序指南进行了递交,并获得用于某特定范畴的资格认定,那么任一医疗器械申请人均可采用该项MDDT,用于其被认定的范畴。在用于上市前递交时,已认证的MDDT不需要重新确认其适用性和有效性,即可用于其被认定的范畴。资格认定可促进MDDT用于各种医疗器械开发过程的可接受性和适用性。同时,已认证的MDDT可被很多申请人使用,为产品开发和评估过程的优化提供帮助。

 

20131114日的联邦公报所探讨的,FDA宣布了该指南草案的有效性,有兴趣人员可在2014212日前提出相关意见。2014815日,FDA开始接受自愿参与MDDT试点的报名。最后,FDA综合考虑了所有收到的公众意见,对该指南进行了适当的修改。目前该指南已正式发布并生效。


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FDA 510K 申报服务和周期(含工厂注册和合同范围内产品列名)
FDA De Novo
FDA MD 预提交(Pre-submission)申报服务和周期
FDA PMA申报服务和周期
FDA产品列名 申报服务和周期
FDA豁免510K-服务


英语原文  


Qualification of Medical Device Development Tools; Guidance for Industry, Tool Developers, and Food and Drug Administration Staff; Availability


AGENCY: Food and Drug Administration, HHS.


SUMMARY: 


The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Qualification of Medical Device Development Tools (MDDT).'' This document formalizes the MDDT program and provides guidance to FDA staff, industry, healthcare providers, researchers, and patient and consumer groups on a new voluntary process within the Center for Devices and Radiological Health (CDRH) for qualification of medical device development tools (MDDT) for use in device development and evaluation programs. In addition, the guidance discusses the framework of an MDDT, including definitions of applicable terms, criteria for evaluating an MDDT for a specific context of use, considerations for qualification, and the contents of a qualification package. FDA considered comments on the draft guidance and revised the guidance as appropriate.

SUPPLEMENTARY INFORMATION:

I. Background


MDDT is a scientifically validated tool that aids device development and regulatory evaluation. The guidance describes the framework and process for the voluntary CDRH qualification of MDDT, including definitions of applicable terms, criteria for evaluating a MDDT for a specific context of use, the threshold for qualification, and the contents of a qualification submission.


The intent of this voluntary qualification policy is to: (1) Enable faster, more efficient development of important life-saving and health promoting medical devices, (2) promote the development of tools to facilitate more timely device evaluation, (3) provide a mechanism to better leverage advances in regulatory science, and (4) more quickly and more clearly communicate with CDRH stakeholders about important advances in regulatory science that may be leveraged to speed device development and regulatory evaluation. CDRH expects the qualification process to expedite development of publicly available tools, which could potentially be used widely in multiple device development programs.
The intent of this voluntary MDDT program is to promote the development and use of tools to streamline device development and evaluation. Once an MDDT is submitted in accordance with the FDA guidance entitled ``Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff'' (Ref. 1) and qualified for a specific context of use, it can be used by any medical device sponsor for that context of use. MDDTs can be used for the qualified context of use without the need to reconfirm the suitability and utility of the MDDT when used in a premarket submission. Qualification may contribute to acceptance and application of MDDTs across multiple medical device development programs. Qualified MDDTs can be utilized by many sponsors to aid in optimizing device development and evaluation.


As discussed in the November 14, 2013, Federal Register notice (78 FR 68459), FDA announced the availability of the draft of this guidance and interested persons were invited to comment by February 12, 2014. In the August 15, 2014, Federal Register notice (79 FR 48170), FDA began accepting nominations for participation in the voluntary MDDT Pilot Program. FDA reviewed and considered all public comments received and revised this guidance as appropriate.

II. Significance of Guidance


This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on ``Qualification of Medical Device Development Tools.'' It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.



内容来自:www.gpo.gov

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