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FDA正式宣布:一般健康设备可豁免FDA的法规监管

来源:奥咨达 2016-08-11 11:40

上周四(2016年7月28日),美国食品药品监督管理局(FDA)发布了一份最终指南(《低风险的一般健康设备的政策》),明确表示FDA不对低风险的一般健康产品(general wellness products)(如:可穿戴的健康监测设备、睡眠跟踪设备)进行监管,FDA将不会要求这类产品满足上市前及上市后的法规要求。

依照该指南,只要这类设备“预期仅用于一般健康用途...且在用户和其他人的安全方面具有超低风险”,便可豁免FDA的法规监管。

在2015年1月20日发布的指南草案中,FDA对“一般健康产品”定义如下:

预期用于维持或鼓励一般健康状况或健康活动的产品;或者

预期通过健康的生活方式帮助降低某些慢性疾病或身体状况的风险或影响的产品,且人们也认识到并接受:选择健康的生活方式可能会对疾病或身体状况产生健康的结果起到重要作用。

按照这些定义,对于其它健康产品,FDA按照先前的指南文件对其进行监管。比如,根据预期用途,移动医疗应用和健身设备应受FDA的法规监管。

若一般健康产品符合上述定义的第1条,制造商便不能以任何形式声称其产品能够影响疾病或身体状况。例如,FDA表示,制造商可以说明其产品可用来帮助控制体重,但不能声称其产品能够治疗或诊断肥胖。

但是,正如FDA Law Blog对去年的指南草案的报道中所指出的那样,符合上述定义第2条的一般健康产品似乎给制造商留有余地,让其产品与某些疾病或身体状况存在一些特定关系但仍在FDA的监管范围之外:

“重点在于制造商可能声称其产品不仅仅只是可以帮助实现某种健康生活方式或帮助减肥。然后将这些结果与某些特定疾病的潜在受益联系起来,从某种程度上来说,就意味着产品本身可以帮助缓解或降低这些疾病所带来的风险。”

就符合上述定义第2条的一般健康产品而言,FDA表示,制造商可以声称其产品预期用于“推动、跟踪和/或鼓励某种(某些)选择作为健康生活方式的一部分,帮助降低某种慢性疾病或身体状况所带来的风险或在某种慢性疾病或身体状况的情况下帮助人们更好的生活。”

举个例子,FDA表示,制造商可以在市场上出售促进身体活动的产品,并且可以声称该产品“可以帮助降低高血压的风险。”(生物谷Bioon.com)

英语原文

FDA Declares ‘General Wellness’ Devices Exempt From Regulations

Posted 28 July 2016 By Michael Mezher

The US Food and Drug Administration (FDA) on Thursday finalized guidance saying that it does not plan to review low-risk "general wellness products", such as wearable fitness monitors or sleep trackers and will not require them to comply with premarket and postmarket regulatory requirements.

Under the guidance, such products are exempt as long as they "are intended for only general wellness use…and present a low risk to the safety of users and other persons."

As in the draft guidance, FDA defines general wellness products to be those with:

an intended use that’s related to maintaining or encouraging a general state of health or a healthy activity; or,

an intended use that relates to the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition.

With these definitions, FDA has kept in line with its previous guidance on other health and wellness products, such as mobile medical applications and exercise equipment, where depending on the product's intended use, it could fall under FDA regulations.

Under the first category, a manufacturer would not be able to make any specific claims about their products’ ability to impact diseases or conditions. For example, FDA says manufacturers could say their product can be used to help with weight management but may not claim the product can treat or diagnose obesity.

However, as FDA Law Blog pointed out in their coverage of the draft guidance last year, the second category appears to give manufacturers some leeway to make specific references to diseases or conditions while remaining outside FDA's purview:

"The significance of this is that the manufacturer may say more about the product than it merely helps achieve a healthy lifestyle or may help aid in weight loss. It can then link those outcomes to potential benefits with specific disease states, implying that the product itself may, to a certain extent, help mitigate or reduce the risk of those disease states."

In this category, FDA says manufacturers could say their product is intended "to promote, track, and/or encourage choice(s), which as part of a healthy lifestyle, may help to reduce the risk of [or may help living well with] certain chronic diseases and conditions."

For example, FDA says a manufacturer could market a product that promotes physical activity and make the claim that the product "may help reduce the risk of high blood pressure."

来自:RAPS (Regulatory Affairs Professionals Society)

整理:奥咨达

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