為疫情急需設備，FDA放下姿態，
為製造商提供便利和指引
FDA於3月24日官網發佈以下一則公示：
FDA通過為PPE及醫械產品製造商提供指引以增加供應
24日，FDA採取行動支持美國政府對新冠疫情的響應，通過向進口製造商提供指引，增加美國個人防護設備和其他醫療設備供應。
FDA應對COVID-19大流行的優先事項之一是要促成一些重要的個人防護設備（PPE）和醫療設備的進口。在本次大流行期間，FDA與進口商和其他與進口貿易界有關的人員接觸，以促成包括PPE產品在內的所需產品進入美國。給進口商的這些指引包括說明了那些無需FDA介入即可進口的PPE產品類型。聲明還包括有關進口商可以提交以方便其進口的信息類型的內容。FDA已經調整了進口篩查流程，以進一步加快合法產品的進口，並將不斷監控其進口系統，以防止和減輕任何潛在的問題。
FDA建立了一個指定的電子郵件收件[email protected]，供美國代理人快速與該機構溝通並解決問題或疑惑。
該機構為尋求將PPE產品引入美國的人士提供最大的靈活性，並隨時準備與進口商進行接觸，以最大程度地減少進口過程中的干擾。
許多公司正在全美範圍內加緊努力，以幫助製造關鍵且可挽救生命的醫療用品，以加強美國的應急響應。為了支持他們的努力，正在建立與FDA的其他交流渠道，以便他們可以全天候與FDA聯繫。
Coronavirus (COVID-19) Update: FDA takes action to increase U.S. supplies through instructions for PPE and device manufacturers
For Immediate Release:
March 24, 2020
Statement From:
Commissioner of Food and Drugs - Food and Drug Administration
Stephen M. Hahn M.D.
Today, the U.S. Food and Drug Administration took action to increase U.S. supplies to support the U.S. response to COVID-19 by providing instructions to manufacturersExternal Link Disclaimer importing personal protective equipment and other devices.
One of FDA’s priorities in combating the COVID-19 pandemic is facilitating access to critical personal protective equipment (PPE) and devices. We are engaging with importers and others involved in the import trade community during this pandemic to facilitate the entry of needed products, including PPE, into the U.S. These instructions to importers clarify the types of PPE that can be imported without engaging with FDA. They also include information about the type of information importers can submit to facilitate their entries. We have adjusted our import screening to further expedite imports of legitimate products and are continually monitoring our import systems to prevent and mitigate any potential issues.
The FDA established a special email inbox, [email protected], for industry representatives to quickly communicate with the agency and address questions or concerns.
The agency is providing maximum flexibility to those seeking to bring PPE into the U.S. and are ready and available to engage with importers to minimize disruptions during the importing process.
Many companies are stepping up across America to help with manufacturing critical and life-saving medical supplies to strengthen the U.S. response. To support their efforts, we are setting up additional avenues of communication to FDA so they can contact us with any questions or concerns around the clock.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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