Clients often ask us how long it will take for their 510(k) submission to clear. The short answer is: it depends. But that answer doesn’t really satisfy most people. A few years ago we decided to take a more scientific approach to the issue and started examining FDA data to see how long it really takes a 510(k) to be cleared by the FDA.
Before we begin, a note about nomenclature. The FDA does not “approve” devices via the 510(k) process - they “clear” them for sale by determining if the applicant’s device is “Substantially Equivalent” to another 510(k) cleared device already legally marketed in the United States. Only devices that go through the Premarket Approval (PMA) process are “approved” by the FDA. Most of these are Class III devices.
With that in mind, we examined more than 24,000 submissions cleared by the US FDA between January 1, 2006 and December 31, 2013. Here’s what we discovered.
On average, it takes 5 months for the FDA to review and clear a medical device 510(k) application.
Back in 2006, it only took 110 days for the FDA to clear a 510(k) application. But from 2006 to 2011, review times gradually lengthened, topping out at 176 calendar days in 2011. The average number of days, it should be noted, is calculated in calendar days from the time the FDA receives a 510(k) submission to the time it is cleared. The good news is that in the last few years the time needed to get a device through the FDA process has stabilized, as you can see below.
FDA Third Party Review may get your product to market faster, but…
The FDA has authorized certain “third parties” to conduct reviews of certain types of medical device 510(k) submissions. If you are in a hurry, and want to try to shave several weeks off the FDA internal review time, you can hire these authorized reviewers to clear your device on behalf of the FDA. However, the FDA still has a final review and must make the final determination of substantial equivalence.
Yes, you’ll pay dearly for this luxury but the additional cost might be offset by getting your device to market faster. Do the math to see if it makes sense for your situation. As you can see above, Third Party Reviewers clear devices about twice as fast as going through the FDA internal review process. Not all products qualify for this route but it’s easy to determine which ones qualify by looking up your device type in the FDA classification database.
About 2/3 of all 510(k) submissions are cleared within 6 months
The FDA sets internal goals to review and respond to 510(k) submissions within 90 days. However, that’s a little misleading when taken at face value. When you submit a 510(k) submission to the FDA, the clock starts. However, when they come back to you with an Additional Information (AI)” request, they stop the clock. The FDA does not count the days when they are waiting on you to provide the additional information they need to determine Substantial Equivalence.
Therefore, many people think they have a good chance of getting their 510(k) cleared within 90 days but the reality is that only 28% of 510(k) submissions cleared in 2013 were done within 3 months. So, the 90 day goal set by the FDA should largely be ignored when you are trying to determine how long it will actually take to get your 510(k) reviewed and cleared.
Results vary widely by device category.
Yes, 166 days is the average number of days it took a traditional 510(k) to be cleared via FDA internal review in 2013. However, some products are reviewed faster, some more slowly. Shown below are the five most common device categories accounting for 60% of all 510(k) submissions. These review times do not include submissions done by Third Party Reviewers.
Total number of 510(k) submissions to the FDA remains stable.
Overall the FDA clears more than 3,000 devices each year. That number has remained fairly stable since 2007, except for a slight dip in 2010. Of the 3,000+ submissions each year, nearly 75% of them are “Traditional” 510(k) submissions. Only 22% are “Special” submissions used for modifications to devices with existing 510(k) clearance. Less than 4% of submissions go through the “Abbreviated” process. These numbers have remained fairly stable since 2006.
Impact of FDA Refuse to Accept policy
Some of you may know that the US FDA implemented a new Refuse to Accept (RTA) program for 510(k) application on January 1, 2013. As the name implies, the FDA no longer accepts 510(k) submissions that do not meet their strict requirements for formatting and completeness. One would expect this to have a positive impact on overall review times as the FDA no longer has to deal with as many incomplete submissions which take much longer to clear. Yet, we have not seen evidence of this so far.
Last year was the first full year of implementation and since the average 510(k) takes 5 months to clear, we can assume that only half the 510(k)s that cleared during 2013 were subjected to the new RTA process. We probably won’t see the true effect until we do an analysis of 2014 data early next year. Until then…
If you have questions about this research please contact:
Emergo Group, Inc.
VP of Global Marketing
Published February 2014.