【奥译言】CDRH降低某些放射学影像设备的器械分类

2018-06-06 14:21 阅读数：4798 标签：

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2018年6月4日 Ana Mulero

本周一，美国食品和药物管理局（FDA）发布了一项提议，将某些医学影像分析仪从III类降至II类。

拟重新分类是FDA为了在上市前和上市后数据间取得更好平衡所正在做出的努力的一部分。

用于检测乳腺癌的乳房X射线照相术、超声波乳房病灶、肺结节放射术和牙龋齿放射学检测的计算机辅助/辅助（CADe）检测设备——指定的产品代码为MYN——将会受到FDA设备和辐射健康中心（CDRH）这一提议的影响。

“这些设备的目的是引导临床医生在解释病人的放射图像时注意到图像中显示异常的那些部分，”CDRH在上周五首次发布的指令中写道。

设备分类的降低旨在减低监管负担和相关成本，因为这种转变使得公司可以从更严格的上市前批准申请（PMA）途径转向上市前通告——这需要向FDA提交510(K)申请。

CDRH说明，“510(K)是一种相对较为简单的上市途径，它通常比PMA更及时地完成上市前评估，并且降低工厂的监管负担，同时也能更及时地向患者提供这些类型的设备。”

该指令还提议为CADe设备创建一个新的分类规则。根据新规定，这些将被视为处方设备，受处方标签要求的限制。

是否适宜重新分类来源于该机构当前对相关数据的审查和分析的理解，包括只有3例召回——其中没有一例是I级——且仅有一份医疗器械报告（MDR），从1998年6月26日首个具有所描述预期用途的设备获得上市前批准开始。由此可得出一个结论，CADe设备的安全描述已经可以分成II类，如类似于那些III类产品的胸部x射线计算机辅助检测系统。

FDA召集了一个放射学设备小组来讨论如何利用这些设备来支持2008年和2009年的临床决策，以便进行重新分类。在确定适当的特殊和一般控制措施以减轻已知的对患者健康的风险，如假阳性和假阴性结果时，这些讨论被考虑在内。

包含图像分析算法的详细描述的设计验证和确认，以及详细的设备标签要求是已识别的控制措施。FDA补充说，在重新分类后，它不打算豁免这些设备的上市前通告。

英文原文

CDRH Down-Classifies Some Radiological Imaging Devices

Posted 04 June 2018 | By Ana Mulero

The US Food and Drug Administration (FDA) on Monday announced a proposal to down-classify certain medical image analyzers from class III to class II.

The proposed reclassification is part of ongoing efforts at FDA to strike an improved balance between pre- and postmarket data.

Computer-assisted/aided (CADe) detection devices for mammography breast cancer, ultrasound breast lesions, radiograph lung nodules and radiograph dental caries detection—assigned product code MYN—would be impacted under FDA’s Center for Devices and Radiological Health (CDRH) proposed order.

“These devices are intended to direct the clinician’s attention to portions of an image that may reveal abnormalities during interpretation of patient’s radiology images by the clinician,” CDRH wrote in the proposed order, first issued Friday.

Device down-classifications are aimed at reducing regulatory burden and the associated costs because the shift allows firms to move away from the more stringent premarket approval application (PMA) pathway toward the that of premarket notification—which requires a 510(k) submission to FDA.

“A 510(k) is a less-burdensome pathway to market a device which typically results in a more timely premarket review compared to a PMA and reduces the regulatory burden on industry in addition to providing more timely access of these types of devices to patients,” CDRH said.

The order also proposes the creation of a new classification regulation for CADe devices. Under the new regulation, these will be considered prescription devices, subject to prescription labeling requirements.

The suitability of the reclassification stems from the agency’s current understanding on reviews and analyses of related data, including only three recalls—none of which were class I—and just one medical device report (MDR), beginning from when the first device for the purposes described received premarket approval in 26 June 1998. This led to the conclusion that the safety profiles for CADe devices already regulated as class II, such as chest x-ray computer aided detection resemble those of class III.

A panel on radiological devices was convened by FDA to discuss how these devices are used to support clinical-decision making in 2008 and 2009 for the purposes of the proposed reclassification. These discussions were taken into consideration in determining the appropriate special and general controls to mitigate the known risks to patient health, such as false positive and false negative results.

Design verification and validation with detailed descriptions of image analysis algorithms, as well as detailed device labeling requirements are among the controls identified. FDA added it does not intend to exempt these devices from premarket notification, following the reclassification.

内容来自：Regulatory Affairs Professionals Society (RAPS)

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