FDA Wants Feedback on Device Premarket Tracker

FDA is inviting feedback on information and features that submitters would find useful in a new progress tracker for premarket submissions the agency is developing. An online notice says FDA “is building a secure, Web-based tracker that displays the progress of a medical device marketing submission throughout FDA’s review process.”

A specific representative of the submitter’s firm named in the submission will be able to view the progress of the submission in a clear and concise format, the notice says.

FDA wants to hear (1) what information is most useful to submitters when they have a premarket submission under review and why; (2) what information or features would improve a challenge submitters currently have with the agency review process for device marketing submissions; and (3) what additional communications methods may be useful when receiving progress information from FDA about device marketing submissions.