Provide Feedback on CDRH's New eSTAR and eCopy Electronic Upload Capability
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. 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.
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 firstname.lastname@example.org.
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.
The FDA built a secure, web-based tracker that displays the Center for Devices and Radiological Health’s (CDRH) progress in reviewing Traditional, Abbreviated, and Special 510(k) submissions. When you submit a 510(k) submission to CDRH for review, your Official Correspondent can monitor the FDA’s progress online in a simple, concise format.
The FDA offers online progress tracking to fulfill its Medical Device User Fee Act (MDUFA) commitments. (See MDUFA IV Commitments letter, page 11: “an industry dashboard that displays near real-time submission status.”)
The FDA secures the information about each submission’s progress so only its Official Correspondent can view it.
- If this is your Official Correspondent’s first time tracking a submission online, the FDA automatically emails them a link to create a login password soon after the FDA starts its review.
- The FDA currently displays progress online for Traditional, Abbreviated, and Special 510(k) submissions.
- The FDA formally notifies you of your submission’s status by emailing your Official Correspondent with official actions and requests.
- If you have questions about how the FDA informs you of your premarket submission’s progress, email email@example.com.