Request for Feedback: Progress Tracker for Premarket Submissions
The FDA is building a secure, web-based tracker that displays the progress of a medical device marketing submission throughout the FDA's review process. Using this tracker, a representative of the submitter's firm will be able to view the progress of its submission in a clear and concise format. Only the representative identified in the submission can access this protected information.
The FDA committed to provide "a new information management system that provides an industry dashboard that displays near real-time submission status" to the medical device industry as part of its MDUFA IV commitments (see MDUFA IV Commitments letter, Section III.C: IT Infrastructure for Submission Management).
The FDA invites you to provide feedback on the features and information you would find useful in this Progress Tracker for Premarket Submissions.
Your Feedback: Please consider the following when providing your feedback:
- What information is most useful to you when you have a premarket submission under review and why?
- What information or features would improve a challenge you currently have with the FDA review process for device marketing submissions?
- What additional communication methods may be useful when receiving progress information from the FDA regarding device marketing submissions? Examples may include emails, text messages, data export tables, or application programming interfaces (APIs).
Deadline: The deadline for feedback for the first version of the progress tracker is October 8, 2020. After the progress tracker is launched, there will be feedback methods available within the tracker itself to inform the design of future versions.
Confidentiality: Feedback may be provided anonymously. The FDA is not requesting or collecting any identifying information and will not publish responses or reply to them.
To submit your feedback, send an email to PremarketProgressTracker@fda.hhs.gov.
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