FDA：可穿戴健康设备≠医疗设备

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                    <p>导读：作为健康领域的一片蓝海，可穿戴健康设备扎推涌入市场。这些号称能管理体重、监测睡眠的科技小玩意儿和真正的医疗设备之间界限越来越不明朗，为了应对这一市场乱象，美国FDA近日宣布将把可穿戴健康设备划入“一般健康”设备的范畴，并制定了相关法规。</p><p style="TEXT-ALIGN: center"><br  /></p><p>　　FDA将“一般健康”设备定义为提高生活质量或有助于体重和睡眠管理的设备，它们的特征是安全风险低，功能限定于以促进健康为目的的体重、睡眠管理、健身、休闲、精神管理等。</p><p>　　这也就意味着，可穿戴健康设备的功能充其量只能标注“管理体重”、“睡眠监测”等功能，而不能声称可以治疗肥胖或失眠，因为后者只有真正的医疗设备才可声称标注。</p><p>　　FDA表示，“一般健康”分级规定并非强制企业遵守，对于生产“低风险健康设备”的企业来说，是否遵守此分级是一种自愿选择。</p><p>　　从企业的角度考虑，划入“一般健康”分级从某种程度上可以帮助其免责，因为不允许标注医疗器械的声称，这些企业也可规避因没能达到承诺的“医疗功能”而被消费者追责的麻烦。据悉，FDA将对这套管理规定公示90天，并征询相关意见。</p><p style="margin-top: 0px; margin-bottom: 0px; padding: 0px; max-width: 100%; min-height: 1em; white-space: pre-wrap; color: rgb(62, 62, 62); line-height: 24px; background-color: rgb(255, 255, 255); font-family: Arial, Verdana, sans-serif; font-size: 12px; box-sizing: border-box !important; word-wrap: break-word !important;">广州市设备维修有限公司<br style="margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;"  /></p><p style="margin-top: 0px; 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