Regulatory Focus™ > News Articles > What's the Best Time to Submit a 510(k) Application to FDA?

What's the Best Time to Submit a 510(k) Application to FDA?

Posted 16 July 2014 | By Sharon DeGrove Bishop, RAC

What's the Best Time to Submit a 510(k) Application to FDA?

Regulatory intelligence is at the heart of every well-informed regulatory decision, and is integral to maximizing effectiveness and influence for the regulatory professional. The Regulatory Intelligence Quotient is a regular exploration of regulatory intelligence topics by thought leaders in the field. Want to learn more or suggest future topics? Contact us at asksofie@graematter.com

What if there was a particular month when your submission would be cleared faster than any other month? Wouldn't it be great to know that your submission is going into the US Food and Drug Administration (FDA) at the optimal time?

While many factors contribute to the timing of submissions, being informed about existing trends makes it much easier to predict how long it might take for an application to be cleared by FDA.

FDA publishes its submission review times in annual summaries, but these summaries provide few details needed for in-depth examination of the results. Using the SOFIETM System for regulatory intelligence, we’ve taken a look at recent average review times for 510(k)s with respect to which month the submission was made.

Here’s what we've found.

Best Time to File a 510(k)

June the Best Month for 510(k)s, September and March the Worst

Taking into consideration all of the traditional 510(k)s that cleared FDA from January 2010 through June 20131, on average, 510(k)s submitted in June appear to have the shortest review times, with the average number of days required to clear the FDA at 144.

Compare this to submissions made in March or September, which both average 167 days to clear. That’s a difference of 22 days, or more than three weeks.

Different Conclusions for Different Specialties

Now let’s consider a particular specialty. We looked at submissions cleared by the Orthopedic reviewing committee, since it’s a busy one.

Best Time to File a 510(k) - Orthopedic

Here again, June looks like a pretty good month to submit, along with October and November.

Although these results are not statistically significant, they are interesting. What’s the reason for the difference in clearance times from month to month? We don’t have an answer, but whatever the reason, 510(k)s filed in June appear to have shorter review times.

We do have some questions we would like to pose to our readers:

  • What would you do with this knowledge? Would this cause you to change your submission strategy?
  • What other questions would you ask to try to better understand what the data here show?

Let us know what you think. To contact us with your thoughts or to request more information, email asksofie@graematter.com or connect with us on LinkedIn, Twitter and Facebook.

 

References

  1. 510(k) Premarket Notification database, downloaded from http://www.accessdata.fda.gov; searched using the SOFIE System by Graematter. Includes 510(k)s submitted and cleared through June 2013.

About the Author

Sharon DeGrove Bishop, RAC, has more than 15 years of regulatory experience with Class I, II and III medical devices and currently oversees all aspects of user interface with the SOFIE™ Regulatory Intelligence System by Graematter. She can be reached at sbishop@graematter.com.


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