為幫助緩解供應壓力，FDA在官網公佈消息，其可以對個人防護類產品，進行快速審查，以應對供應短缺的局面。
這意味著，還沒有取得FDA認證的國內產品，按照其指引提交申請資料，有機會加快FDA註冊的進程，趕上這一波中國口罩賣全球之美國篇。
以下是FDA發佈消息的要點：
一、個人防護用裝備（PPE）供不應求。
二、FDA正努力緩解這一供求緊張局面，與業界展開合作。
三、措施之一就是對產品上市前的FDA認證申請進行快速審查。
四、這些產品及FDA代碼有：
外科口罩（FXX）
帶有抗菌/抗病毒劑的外科口罩（OUK）
兒科/兒童口罩（OXZ）
外科手術服（FYA）
隔離服和手術服配件（FYC，LYU，OEA）
手術服套裝（FXO）
五、加快審查專用郵箱：[email protected]
六、申請郵件格式指引：
電子郵件的主題： “產品代碼XXX，緩解短缺方案”。
描述受影響的一個或多個產品，包括品牌名稱，型號，510（k）編號（注：指已經獲得FDA註冊的產品）等。
描述提議的緩解方法。
確定您想讓FDA解決的訴求，例如：加快上市前審查（注：針對未獲批的產品），或者快速審查生產地點變更(針對III類設備製造商），或者有關進口某些產品的內容。
附：FDA發佈內容原文。
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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