FDA发布终版医疗器械生产地址变更指南

美国食品药品监督管理局(FDA)发布了旨在帮助业界确定医疗器械生产场所变更适用要求的终版指南文件。

这份19页的指南与2015年发布的草案大体相似，包含了生产地址的变更是否需要提交上市前批准申请(PMA)补充或“30天通知”的说明，对原草案中关于是否需要进行批准前预审查一项，做了一定的政策补充说明。

“申请人在更换生产地址时，需要提交‘180天的PMA补充资料申请’……这一变化会影响器械的安全性或有效性”，FDA在草案中对地址变更做了上述补充，而非30天通知。“与工厂搬迁没有直接关系的生产工艺变更应单独提交(通过30天通知或PMA年度报告方式)，不会被认为是生产地址变更补充申请的一部分。”

终稿指南文件还在草案基础上，对FDA的设备和放射卫生中心(CDRH)及生物制品评价和研究中心(CBER)提供了第四种评判标准，用来判定是否须按照21 CFR Part 820的要求，对“生产变更补充申请”的新生产地址实施检查。FDA表示：“该指南将帮助企业管理生产地址、任何工艺流程、方法、程序、资质和验证相关变更的时间框架。”

这项新标准提及，CDRH和CBER一般会一定程度上依据“与生产过程相关的召回和不良事件的审查”，做出是否检查的决定。另外三个标准为上一次现场检查的日期和产品分类，上一次质量体系检查的相关性，以及“与在新地址进行的生产活动有关的器械安全性或有效性的风险”。

定稿的指南文件也做了说明，“制造商可与FDA有关部门联络，讨论是否需要进行批准前检查；在适当的情况下，也可以使用‘预提交’方式进行沟通交流。”该政策适用于已获批PMA，产品开发协议或人道主义器械豁免的企业。

英文原文

FDA Finalizes Guidance on Changes to Device Manufacturing Sites

The US Food and Drug Administration (FDA) issued final guidance intended to help industry determine applicable requirements for a change to a medical device manufacturing site.

The 19-page guidance is largely similar to the draft version released in 2015. It includes a few new clarifications around whether a change to a manufacturing site is likely to require a premarket approval application (PMA) supplement or is eligible for a 30-day notice. Certain policies were added to the draft section on whether a preapproval inspection may be needed. 

“An applicant should submit a 180-day PMA supplement for using a different site…that affects the device’s safety or effectiveness,” FDA added to the draft section on site change supplements versus 30-day notices. “Manufacturing process changes that are not directly associated with the facility move should be submitted separately [via a 30-day notice or a PMA annual report] and are not considered part of the manufacturing site change supplement.”

The final guidance also added a fourth criterion to those in the draft under the approach used by FDA’s Center for Devices and Radiological Health (CDRH) and its Center for Biologics Evaluation and Research (CBER) to determine whether to conduct an inspection of a new manufacturing site associated with a site change supplement to evaluate implementation of quality system requirements under 21 CFR Part 820. “As a result, this guidance should help firms manage the timeframes associated with implementing the changes in the manufacturing site and any processes, methods, procedures, qualifications and validations,” the agency said.

CDRH and CBER will generally reach these decisions on inspections partly based on “a review of relevant recalls and adverse events, associated with manufacturing processes,” the new criterion states. The other three relate to dates of last site inspections and their classifications, relevance of the last quality system inspection, as well as “the risk to the safety or effectiveness of the device associated with the manufacturing activities performed at the new site.”

The finalized version of the guidance also clarified “manufacturers may contact the appropriate office to discuss whether a pre-approval inspection may be required; the pre-submission process may be utilized for these interactions, if appropriate.” The polices are limited to firms with approved PMAs, product development protocols or humanitarian device exemptions.

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