FDA is building a web-based tracker that displays the progress of a medical device marketing submission throughout the agency's review process. The agency is accepting industry feedback between now and Oct. 8 on the features and information medical device companies would find useful in this tracker.
The tracker is being developed as part of FDA's committment 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).
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.
FDA asked the industry to consider the following when providing feedback on this tracker:
- 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).
After the progress tracker is launched, FDA said there will be feedback methods available within the tracker itself to inform the design of future versions.
The agency said feedback may be provided anonymously. FDA is not requesting or collecting any identifying information and will not publish responses or reply to them.
To submit feedback, send an email to PremarketProgressTracker@fda.hhs.gov.