为疫情急需设备，FDA放下姿态，
为制造商提供便利和指引
FDA于3月24日官网发布以下一则公示：
FDA通过为PPE及医械产品制造商提供指引以增加供应
24日，FDA采取行动支持美国政府对新冠疫情的响应，通过向进口制造商提供指引，增加美国个人防护设备和其他医疗设备供应。
FDA应对COVID-19大流行的优先事项之一是要促成一些重要的个人防护设备（PPE）和医疗设备的进口。在本次大流行期间，FDA与进口商和其他与进口贸易界有关的人员接触，以促成包括PPE产品在内的所需产品进入美国。给进口商的这些指引包括说明了那些无需FDA介入即可进口的PPE产品类型。声明还包括有关进口商可以提交以方便其进口的信息类型的内容。FDA已经调整了进口筛查流程，以进一步加快合法产品的进口，并将不断监控其进口系统，以防止和减轻任何潜在的问题。
FDA建立了一个指定的电子邮件收件[email protected]，供美国代理人快速与该机构沟通并解决问题或疑惑。
该机构为寻求将PPE产品引入美国的人士提供最大的灵活性，并随时准备与进口商进行接触，以最大程度地减少进口过程中的干扰。
许多公司正在全美范围内加紧努力，以帮助制造关键且可挽救生命的医疗用品，以加强美国的应急响应。为了支持他们的努力，正在建立与FDA的其他交流渠道，以便他们可以全天候与FDA联系。
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.
閱讀更多 奧諮達醫療器械 的文章
