FDA recently released a report analyzing 510(k) review time. The analysis showed that review times have increased due to the poor quality of data and information provided as part of the 510(k) submission. FDA requests for additional information from submissions steadily increased from 38% in 2001 to 77% in 2010. Requests for additional information obviously increases review time.
CQ has been involved with quite a few 510(k)s during this period of time, ranging from large to early stage start-up medical device companies. Some of the companies we’ve worked with were submitting their very first 510(k), while others were “old pros”. Based on my experiences and anecdotes from my business partner, I definitely agree with the conclusions of this analysis. There were some 510(k)s that probably lacked key data and information. And we received requests for additional information from FDA. The submissions which were more thorough had quicker reviews. Yes, sometimes these also received requests for more information. However, these cases were usually handled via email correspondence and phone calls, all while not stopping the review time clock.
Start-ups seem especially anxious to submit a 510(k) to FDA, usually because this milestone is directly linked to a fund-raising event. I blogged about this some time ago. I think the more meaningful milestone is 510(k) clearance but understand somewhat why there is emphasis on the submission. Regardless, the FDA analysis indicates quality of submission has a direct correlation to review time. Start-ups (and others submitting 510(k)s) take note.
You can read a couple other posts on this topic by clicking the links below: