FDA Posts 510(k) Communication Timeline

FDA has developed a timeline that provides 510(k) applicants with an understanding of communication during the review process.

FDA has updated its Premarket Notification 510(k) website page with a timeline that provides applicants with an understanding of communication during the review process. The chart documents each step of the process that leads to the goal of FDA sending the final MDUFA decision by day 90.

The timeline is based on calendar days and suggests that the multiple stages of the review will take place usually by the following days:

Day 1: FDA receives 510(k) application
By Day 7: FDA sends Acknowledgement Letter or Hold Letter
By Day 15: FDA conducts Acceptance Review
By Day 60: FDA conducts Substantive Review
By Day 90: FDA sends final MDUFA Decision
By Day 100: If decision is not reached, FDA provides Missed MDUFA Decision Communication that identifies outstanding issues.

Companies that expect to submit medical devices for approval can also look forward to more about communicating with FDA during the process. FDA has listed finalizing the guidance document “Types of Communication During the Review of Medical Device Submissions” as a 2014 priority.

The 510(k) timeline can be found by clicking here.
More on the 510(k) process, including orthopaedic-related clearances, can be found by clicking here.