Devices

CDRH Seeks Feedback on eSubmission Process

CDRH is seeking feedback on its new eSTAR and eCopy electronic submission process for 510(k) and De Novo device submissions. Effective 7/18, existing users of the Center’s Customer Collaboration Portal’s progress tracker will be able to try out the process and provide user feedback on the tool. To participate in the trial process, users must:

Be the official correspondent for their organization’s use of the Customer Collaboration Portal
Have received an email from the FDA letting them know they are eligible

The online submission process was mandated under the user fee agreements. “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,” an agency notice says.

CDRH Seeks Feedback on eSubmission Process

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