【奥译言】美国FDA即将取消医疗器械替代性总结报告

2019-05-06 09:28 阅读数：3331 标签：

美国食品药品监督管理局（FDA）于5月3日宣布，在未来几周内，FDA将取消一项针对医疗器械的替代性总结报告计划。与此同时，FDA还宣布，毛面乳房植入物假体将会继续留在美国市场销售。

“对于过去通过总结报告收到的数据，FDA还将在未来几周内对外公开这些数据，包括该计划下的所有医疗器械的替代性总结报告。”美国FDA表示。

接下来，将要求乳房假体和其他器械制造商提交单独的医疗器械报告，而这些报告将在FDA的器械相关不良事件数据库MAUDE中对外公开。

在FDA决定取消替代性总结报告计划之前，凯泽健康新闻（Kaiser Health News，KHN）最近的一项调查显示，自2016年以来，FDA通过替代性总结报告计划共收集了110万份报告。

FDA认为，除上市后电子表格报告（Postmarket Spreadsheet Reports）外，自2017年以来的其他所有总结报告数据目前都可从MAUDE数据库获得。

但FDA向KHN提供的数据显示，在2018年前9个月里，FDA持续收到超过19万份受伤报告和4.5万份故障报告。

FDA还表示，其机构已经取消了上市后电子表格报告，该报告旨在有效审查与硅胶乳房假体相关的不良事件。而器械制造商仍然可以提出某些豁免或替代性报告的要求。

“依据相关法律, 制造商可根据21 CFR 803.19的规定提出器械豁免、变更或替代性报告的要求。FDA表示：“根据具体情况将继续考虑这些请求，但有批准条件，以确保公众可以在线获得数据。”

英文原文

FDA to End Alternative Summary Reporting for Devices

In the coming weeks, the US Food and Drug Administration (FDA) will sunset an alternative summary reporting program for medical devices, the agency announced Thursday alongside its notice that textured breast implants would remain on the US market.

“For past data received through summary reporting, the agency will also be making this data, including alternative summary reports for all devices under the program, publicly available in the coming weeks,” the agency said.

And moving forward, breast implant and other device manufacturers will be required to file individual medical device reports that will be publicly available in MAUDE, which is FDA’s database of device-related adverse events.

The decision to end the alternative program follows a recent Kaiser Health News (KHN) investigation that showed how FDA had collected 1.1 million reports through the alternative summary program since 2016.

FDA maintains that all alternative summary reporting data since 2017, except for Postmarket Spreadsheet Reports, are currently available in MAUDE.

But FDA data provided to KHN shows that during the first nine months of 2018, FDA continued to accept more than 190,000 injury reports and 45,000 malfunction reports under the alternative reporting program.

FDA also says it has ended the Postmarket Spreadsheet Reports, which were designed for the efficient review of adverse events linked to silicone breast implants.

And device makers will still be able to request certain exemptions or alternatives to reporting requirements.

“By law, a manufacturer may request, under 21 CFR 803.19, an exemption, variance or alternative to reporting requirements under 21 CFR Part 803. These requests will continue to be considered on a case-by-case basis going forward but will include conditions of approval that will ensure availability of data to the public online,” FDA says.

来源：RAPS

原文链接：https://www.raps.org/news-and-articles/news-articles/2019/5/fda-to-end-alternative-summary-reporting-for-devic

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