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The FDA is developing a new way for industry to electronically upload CDRH-led premarket medical device submission files in the eSTAR (510(k) and De Novo) and eCopy formats. 

FDA正在為行業(yè)開發(fā)一種新的方式，以電子方式上傳由CDRH主導(dǎo)的eSTAR（510（k）和De Novo）和eCopy格式的上市前醫(yī)療器械遞交文件。

Effective July 18, 2022, existing users of the Customer Collaboration Portal's progress tracker will have the opportunity to try out the process and provide crucial user feedback to the FDA about the tool.

自2022年7月18日起，客戶協(xié)作門戶網(wǎng)站的進(jìn)度跟蹤器的現(xiàn)有用戶將有機(jī)會(huì)試用該程序，并向FDA提供有關(guān)該工具的關(guān)鍵用戶反饋。

To participate in this trial process, you must:

Be the official correspondent for your organization's use of the Customer Collaboration Portal

Have received an email from the FDA letting you know you are eligible. These emails are sent from ccp@fda.hhs.gov.

要參與此試用過程，您必須：

成為貴組織使用客戶協(xié)作門戶的官方通訊員；

已收到FDA的電子郵件，告知您符合資格。這些電子郵件來(lái)自ccp@fda.hhs.gov.

This effort is part of the FDA's ongoing commitment to work together with industry and enhance efficiency in the medical device review process. Long term, this submission process will be made available to all industry partners and will replace the need to create and mail to the FDA any compact discs (CD), digital video discs (DVD), or flash drives containing eSTAR or eCopy files.

這項(xiàng)工作是FDA與業(yè)界合作并提高醫(yī)療器械審查過程效率的持續(xù)承諾的一部分。從長(zhǎng)遠(yuǎn)來(lái)看，該遞交流程將向所有行業(yè)合作伙伴提供，并將取代制作包含eSTAR或eCopy文件的任何光盤（CD）、數(shù)字視頻光盤（DVD）或閃存驅(qū)動(dòng)器并將其郵寄給FDA的需求。