【奥译言】美国FDA发布医疗器械企业检查指南草案

2019-04-01 10:58 阅读数：3223 标签：

美国食品药品监督管理局（FDA）于周四（3月28日）公布了一份指南草案，旨在对国内外的医疗器械企业实施统一的FDA检查流程和标准。

FDA更新了医疗器械企业检查（有因检查除外）的流程和标准，以确保检查流程和标准的统一性，并设立了针对医疗器械企业检查的标准时间范围。“FDA调查人员通过统一检查的实施方法，可以为企业的准备工作提供信息，并为双方设定基线沟通和时间预期”，FDA表示。

这份三页的指南草案符合2017年颁布的FDA再授权法案（FDARA）的要求，提供了检查过程中的标准化沟通方法。在该指南草案中，还确定了FDA调查人员和医疗器械企业为确保检查连续性应采取的做法。

此外，该草案也提供了此类检查流程和标准的例外情况（视情况而定）、检查流程的预计时间范围以及现场检查时要求医疗器械企业提供某些记录的提前通知（在可行情况下）。FDA实施统一的流程和标准旨在帮助其及时进行检查。

FDA检查一般持续3~6个工作日，检查持续时间受诸多因素影响（如FDA在检查中发现的不符合项的性质），并且在某些情况下可能会有所延长。

根据统一的检查流程和标准，FDA将在五个日历日内预先公布在国内实施的检查。而对于在国外实施的检查，可能会因当地国家的许可要求出现延迟的情况。“在时间和情况允许的情况下”，FDA调查人员应“采取一切合理措施，在检查时与医疗器械企业管理层讨论所有的不符合项（观察项），当然此类讨论也可每日进行，以便尽量减少错误和误解。”

FDA器械和放射健康中心（CDRH）上个月发布了一份指南草案，旨在就医疗器械企业确定一种新的标准化机制，医疗器械企业可以就其为解决FDA 483表格所提出的问题而准备采取的行动向FDA提出非约束性反馈的请求。FDA发布该指南草案也正好符合FDARA再授权法案第702节的规定。CDRH报告称，2007年至2017年期间，国外医疗器械企业年度检查数量增加了243％，国内检查数量增加了46%，这突出表明FDA迫切需要实施新的指南，以便促进检查过程前后的协调性。

FDA最近开始根据FDARA再授权法案的规定，在年度报告中编制关于药品和器械审批检查的若干数据点。FDA在2018年3月公布的年度报告指出，从发出FDA检查请求到开始医疗器械企业检查的中位时间间隔为35天。

与此同时，CDRH生物统计部门正在开发一种新型软件工具（称之为BLISS），该工具旨在建立一种生产场地选择流程的标准化方法。

英文原文

FDA Drafts Guidance on Inspections of Medical Device Establishments

The US Food and Drug Administration (FDA) issued draft guidance on Thursday to implement uniform processes and standards for FDA inspections of domestic and foreign medical device establishments.

FDA has updated processes and standards for uniformity within and across inspections other than for-cause and to establish a standard timeframe for such inspections of device establishments. The uniformity in FDA investigators’ approaches to these inspections “may inform firms’ preparation for the inspection and set baseline communication and timing expectations for each party,” the agency said.

The three-page draft guidance, which satisfies a requirement established by the FDA Reauthorization Act of 2017 (FDARA), provides for standardized communication methods during the inspection process. Practices for both FDA investigators and device establishments to facilitate the continuity of inspections are identified in the draft guidance as well.

The updates provide exceptions to such processes and standards, as deemed appropriate, an estimated timeframe for an inspection process and advanced notices, as feasible, of some records that will be requested from the establishment at the time of the site inspection. The uniform processes and standards are meant to help an inspection be conducted in a timely manner.

The agency’s inspections can range from three to six continuous business days, though factors such as the nature of FDA-observed deficiencies can impact inspection duration and extensions may be needed under certain situations.

With the uniform processes and standards, FDA will pre-announce a domestic inspection generally within five calendar days. For foreign inspections, this may be delayed due to countries’ clearances requirements. FDA investigators, “when time and circumstances permit,” are to “make every reasonable effort to discuss all observations with the management of the establishment as they are observed, or on a daily basis, to minimize errors and misunderstandings.”

FDA’s Center for Devices and Radiological Health (CDRH) issued draft guidance last month to identify a new standardized mechanism for device establishments to request nonbinding feedback on actions proposed to address FDA Form 483 observations. This draft guidance was also issued for FDA to comply with section 702 of FDARA. CDRH reported a 243% increase in the annual number of foreign device inspections and a 46% increase in that of domestic inspections between 2007 and 2017, underscoring the need for the new draft guidances to facilitate coordination before and after the inspection process.

The agency recently began compiling several data points on inspections for drug and device approvals in annual reports in line with provisions of FDARA. Its March 2018 annual report noted the median time between an FDA inspection request to the start of an inspection of a device establishment is 35 days.

A new software tool, meanwhile, that seeks to establish a standardized approach to the manufacturing site selection process has been in the works at CDRH’s Division of Biostatistics. The tool is called BLISS.

来源：RAPS

原文链接：https://www.raps.org/news-and-articles/news-articles/2019/3/fda-drafts-guidance-on-inspections-of-medical-devi

整理翻译：奥咨达

奥咨达翻译服务

奥咨达翻译团队根植于中国，面向全球，专注为医疗器械领域的企业提供专业、高效的翻译解决方案。翻译领域包括医疗器械的研发、注册、临床、上市后监督、营销、管理、培训等，译稿已涵盖医疗器械领域的所有类型。

奥咨达翻译组联系方式：

邮箱：trans@osmundacn.com