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正在为行业开发一种新的方式，以电子方式上传由CDRH主导的eSTAR（510（k）和De Novo）和eCopy格式的上市前医疗器械递交文件。

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，客户协作门户网站的进度跟踪器的现有用户将有机会试用该程序，并向FDA提供有关该工具的关键用户反馈。

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.

要参与此试用过程，您必须：

成为贵组织使用客户协作门户的官方通讯员；

已收到FDA的电子邮件，告知您符合资格。这些电子邮件来自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.

这项工作是FDA与业界合作并提高医疗器械审查过程效率的持续承诺的一部分。从长远来看，该递交流程将向所有行业合作伙伴提供，并将取代制作包含eSTAR或eCopy文件的任何光盘（CD）、数字视频光盘（DVD）或闪存驱动器并将其邮寄给FDA的需求。