How Long Does a 510(k) Approval Actually Take? 2021 edition

It is a common question asked by those involved in medical device design — how long is my 510(k) approval going to take? The timeline for 510(k) review and clearance (approval) can have significant impact on strategic company planning, investor decisions, etc. so it can be critical to have realistic expectations for the process.

We ran the numbers, thanks to the availability of data from open.fda.gov. The FDA has a goal of providing 510(k) decisions within 90 “FDA days.” FDA days are the number of calendar days between the date the 510(k) was received and the date of final decision, excluding the days the submission was on hold for an Additional Information (AI) request.

METHOD: We analyzed all 1422 Traditional 510(k) submissions which were cleared in 2021 between Jan 1st and Aug 8th and compared the Date Received by the FDA to the Decision Date to determine the total days to clearance for each 510(k). There were 11 outliers with a review time of >600 days which we removed from the analysis (the longest time to approval being 1178 days!).

The average time for 510(k) clearance in 2021? 175 DAYS.

It is worth noting that the most common time window to clearance (median) is 80-90 days, followed very closely by 50-60 days. It is also important to consider that these clearance times include FDA days (time the FDA spends reviewing the application) as well as the time required by the submitting company to respond to any AI requests from the FDA.

There is a wide range on the clearance time for 510(k) applications. One key consideration for minimizing that time is having the right team in place with the experience and expertise to compile a thorough and complete 510(k) submission which avoids AI requests and streamlines the FDA review.