为帮助缓解供应压力，FDA在官网公布消息，其可以对个人防护类产品，进行快速审查，以应对供应短缺的局面。
这意味着，还没有取得FDA认证的国内产品，按照其指引提交申请资料，有机会加快FDA注册的进程，赶上这一波中国口罩卖全球之美国篇。
以下是FDA发布消息的要点：
一、个人防护用装备（PPE）供不应求。
二、FDA正努力缓解这一供求紧张局面，与业界展开合作。
三、措施之一就是对产品上市前的FDA认证申请进行快速审查。
四、这些产品及FDA代码有：
外科口罩（FXX）
带有抗菌/抗病毒剂的外科口罩（OUK）
儿科/儿童口罩（OXZ）
外科手术服（FYA）
隔离服和手术服配件（FYC，LYU，OEA）
手术服套装（FXO）
五、加快审查专用邮箱：[email protected]
六、申请邮件格式指引：
电子邮件的主题： “产品代码XXX，缓解短缺方案”。
描述受影响的一个或多个产品，包括品牌名称，型号，510（k）编号（注：指已经获得FDA注册的产品）等。
描述提议的缓解方法。
确定您想让FDA解决的诉求，例如：加快上市前审查（注：针对未获批的产品），或者快速审查生产地点变更(针对III类设备制造商），或者有关进口某些产品的内容。
附：FDA发布内容原文。
How can manufacturers of personal protective equipment (PPE) who may be considering increasing availability of these products to the US market engage with the FDA?
The FDA recognizes that the need by healthcare providers and personnel for personal protective equipment (PPE) such as surgical masks and surgical and isolation gowns, may outpace the supply during the Coronavirus Disease 2019 (COVID-19) outbreak.
The FDA is collaborating with manufacturers of personal protective equipment (PPE) to help facilitate mitigation strategies related to the COVID-19 outbreak. The FDA’s door is open, and we are available to collaborate with stakeholders.
To help alleviate supply pressures, the FDA may consider expedited review of manufacturing site changes or premarket submissions—manufacturers of PPE (particularly surgical masks and surgical or isolation gowns) may contact FDA regarding plans to increase availability of these products to the U.S. market.
For reference, the applicable product codes discussed in these FAQs are:
- Surgical masks (FXX)
- Surgical mask with antimicrobial/antiviral agent (OUK)
- Pediatric/child facemask (OXZ)
- Surgical gowns (FYA)
- Isolation gowns and surgical apparel accessories (FYC, LYU, OEA)
- Surgical suits (FXO)
FDA is interested in hearing from manufacturers who may be able to help mitigate potential shortages of the above product codes by increasing U.S. availability of such devices. These manufacturers may email FDA at [email protected], which is closely monitored and has proven to be a valuable resource thus far in helping FDA mitigate potential supply chain disruptions.
To facilitate a rapid response to your email, please see an example of information that FDA would find helpful to have initially below:
Subject of the email: “Product Codes XXX, Shortage Mitigation Options for FDA Engagement,” where XXX represents the product code(s).
Body of the email:
- Describe the affected product or products which may include the brand name, model number, 510(k) number, etc.
- Describe the proposed mitigation approach.
- Identify what you are interested in discussing with FDA, such as:
- Expedited review of a premarket submission, or
- Expedited review of a manufacturing site change if you are a class III device manufacturer, or
- Information about importing certain products.
摘自：https://www.fda.gov/
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