FDA发布执法政策来解决冠状病毒个人防护设备短缺的问题

2020年4月6日 冠状病毒资源中心:返回业务 博客
作者: 内森·海狸 戴维·罗森 保罗·约瑟夫 卡拉·肖恩诺夫

在COVID-19大流行之后,FDA寻求为大众和医疗保健专业人员扩大所需的个人防护设备(PPE)的可用性。例如,最近,FDA公布了两项强制执行政策,宣布放宽某些针对以下方面的上市前审查要求:(1) 口罩s and specific respirators (包括N95防毒口罩)和(2) 手术服装,包括袍子和头巾,以及用于患者检查和手术的检查手套。  As an example of how swiftly regulatory authorities are moving to incorporate developments to date, the guidance for 口罩s and respirators superseded the prior version for those products issued just the week before, on March 25, 2020. These policies are of particular interest not just to traditional medical 设备 manufacturers but those in other industries pivoting to help increase the supply of PPE. 

Under the newly published policies, FDA will not enforce premarket notification (510(k)), registration and listing, quality system regulation (QSR) requirements or unique 设备 identification requirements for medical 口罩s and surgical 口罩s if the masks contain appropriate warnings and meet other criteria to prevent 过度风险s to health. 同样,FDA不会对各种礼服,服装和手套执行某些法规要求。这两项强制执行政策为寻求在COVID-19期间合法销售PPE的利益相关者提出了许多问题。

口罩常见问题

我计划销售医疗用口罩,但不提供液体屏障保护。  The guidance states that the products are eligible for certain relaxed premarket review rules, as long as they 不要 create 过度风险.  What constitutes 过度风险?    

FDA认为,用于医疗目的的口罩(带或不带面罩)均适用,但 intended to provide liquid barrier protection, 不要 create an 过度风险 as long as they meet the following criteria:

  • 它们被准确地标记为“face mask”(不作为口罩或过滤式面罩呼吸器(FFR)使用);
  • 标签包括一系列与身体接触的材料,不得包含任何添加的药物或生物制剂;
  • 标签上包含适当的警告和注意事项,以确保安全使用(例如,建议不要在外科手术环境中使用,或在可能会大量接触液体,身体或其他有害流体,在临床环境中使用或在高剂量环境中使用的场合) -强度热源或可燃气体;
  • 该标签包括有关使用限制的适当披露(例如,明确说明该面罩并非旨在用于抗微生物或抗病毒保护或预防感染,并且不包含微粒过滤要求)。

为了节省有限的资源,我想对一次性口罩或过滤式口罩呼吸器(FFR)进行消毒,以便再次使用。 指导是否允许我这样做?  

Reprocessing of single-use medical 设备s generally requires submission of a 510(k).  However, 为了鼓励在保护安全的PPE的同时确保安全地重复使用,FDA通过其紧急使用授权(EUA)流程创建了快速评估程序。 在整个公共卫生紧急事件进行期间,建议制造商以其他方式处理的一次性口罩或FFR进行消毒,请联系FDA并向其提供某些信息。 [email protected](如果有),有关后处理程序。 为了帮助促进EUA之前的讨论,FDA建议制造商提供指导文件第9页和第10页上列出的七类信息中列举的尽可能多的数据,包括对消毒/净化过程和控制措施的描述。 。   

礼服,服装常见问题解答& Gloves

我想销售要求中度到高级屏障防护的礼服,例如ANSI / AAMI PB70 3级或4级。我需要通知FDA吗? FDA是否放弃了任何上市前批准要求?

In short, during the course of this public health emergency, the FDA does not require premarket notification for these types of gowns and has waivers for other premarket approval requirements, so long as the gowns 不要 create an 过度风险. 

作为背景,要求中度到高级屏障防护的礼服,例如ANSI / AAMI PB 70 Level 3或4,受到FDA的监管。“surgical gowns.”FDA认为手术衣风险更高“device” than gowns that claim minimal or low levels of barrier protection. This is because these gowns are intended to be worn by operating room personnel during surgical procedures to protect both the patient and operating room personnel from transfer of microorganisms, bodily fluids, and particulate material in moderate- or high-risk situations. Therefore, these gowns have substantial importance in preventing impairment of human health. In fact, the FDA considers such gowns to be class II 设备s, and, as a result, they are typically subject to the FDA’510(k)要求以及FDA’s general controls. 

尽管通常在COVID-19公共卫生紧急事件期间,根据新的执法政策,这些礼服必须服从那些法规要求,但FDA表示,中级到高级屏障防护礼服的制造商和分销商 不要 需要:  

  • 提交上市前通知; 
  • 遵守21 CFR 807中的注册和列出要求;要么 
  • 对于要求中度或高级屏障防护的礼服,请遵守21 CFR 830和801.20部分中的唯一设备标识(UDI)要求。 

This assumes that the surgical gowns 不要 create an 过度风险 in light of the public health emergency. 

I am planning to market 手术衣。  The guidance states that these products are eligible for certain relaxed premarket review rules as long as they 不要 create 过度风险.  What constitutes 过度风险 in this context?    

FDA currently believes surgical gowns 不要 create such an 过度风险 where: 

  • 达到3级或更高级别的液体屏障保护,对于关键区域,符合ANSI / AAMI PB70;符合16 CFR Part 1610的I级或II级易燃性标准;如果打算用于外科手术环境,则已证明是无菌的;
  • 该产品包括准确描述该产品的标签’无菌状态(无菌或非无菌),包括使用的任何灭菌方法,屏障防护等级为3,易燃性分类(I级或II级)以及与人体接触的材料清单;
  • The product includes labeling with general statements and makes recommendations that would sufficiently reduce the risk of use, for example, a general statement about 设备s that have not been cleared by FDA, recommendations against use when FDA-cleared surgical gowns are available, and recommendations against use of non-sterile products in surgical settings; and
  • The product is not intended for any use that would create an 过度风险 in light of the public health emergency, for example, the labeling does not include uses for antimicrobial or antiviral protection; uses for infection prevention or reduction; or is labeled as having ANSI/AAMI PB70 Level 4 liquid barrier protection.

我计划在销售礼服时不要求任何抗病毒,抗菌保护或用于预防感染或减少感染的要求。这些手术服是否要经过FDA上市前审查? 

如果您忽略了有关抗病毒,抗微生物保护或用于预防感染或减少感染的要求,则礼服符合以下条件:“non-surgical,”无需FDA上市前审查。假设基于FDA,礼服没有造成不适当的风险’s “undue risk”非手术和最小至低阻隔手术服装的因素: 

  • 该产品包括准确描述该产品的标签 as a “gown,” or “toga,”或其他服装(相对于“surgical 袍,” or “surgical toga”)并包括与身体接触的材料的清单(不包括任何药物或生物制剂);
  • 该产品包含的标签提出了可以降低使用风险的建议,例如,针对以下方面的建议:在手术环境中使用或可能会大量暴露于液体或其他有害流体的环境中,在3级临床环境中使用或4保证被保护,并在高强度热源或可燃气体存在的情况下使用;和 
  • The product is not intended for any use that would create an 过度风险 in light of the public health emergency (like uses for antimicrobial or antiviral protection or uses for infection prevention or reduction or related uses).

从我的研究中,我知道病人检查手套通常要接受FDA的检查’510(k)的要求,以及注册和列表,质量体系法规,唯一设备标识和某些报告要求。我对制造患者检查手套有帮助,以解决PPE短缺的问题。 FDA是否放弃其任何标准的上市前审查要求?

Yes. The new enforcement policy states that the FDA does not intend to enforce any of the standard premarket requirements you mentioned for these gloves provided that the product labeling does not create 过度风险. FDA believes that such 设备s 不要 create an 过度风险 where, for example, the product includes labeling that: 

  • 准确地将产品描述为“unpowdered glove”(相对于外科医生’或患者检查手套); 
  • 单独包装时(非无菌)准确描述其无菌状态; 
  • 不声称该产品不含特定材料(例如不含乳胶);和 
  • 包括身体接触材料的列表。 

In summary, it is important for medical 设备 manufacturers and distributors to understand the FDA’现行的PPE产品执法政策。  For more information about current guidance, please contact your 佛利 relationship partner. 有关可用于帮助您监控冠状病毒在全球范围内传播的其他基于Web的资源,您不妨访问以下网站: CDC 世界卫生组织

佛利 has created a multi-disciplinary and multi-jurisdictional team, which has prepared a wealth of topical client resources and is prepared to help our clients meet the legal and business challenges that the coronavirus outbreak is creating for stakeholders across a range of industries. 点击这里 for 佛利’冠状病毒资源中心可随时了解相关发展,见解和资源,以在这个充满挑战的时期为您的业务提供支持。要直接在收件箱中接收此内容, 点击这里 并提交表格。 

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