How Long Does The FDA 510(k) Review Process Really Take?

Emergo Group recently published the results of an eight-year study of FDA 510(k) review practices. The compiled data reveals a number of important trends relating to the length of time required for a 510(k) submission to clear, information that may be helpful to companies strategizing how to effectively get their devices to market.

“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,” said Chris Schorre, VP of Global Marketing at Emergo, in a recent blog post. “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.”

The study looked at over 24,000 510(k) medical device submissions cleared between January 1, 2006 and December 31, 2013.

After compiling and analyzing the data, Emergo highlighted the following as particularly important findings:

1. It takes an average of five months for a 510(k) submission to clear. More specifically, Emergo discovered that between 2006 and 2011 the length of time it took for 510(k) submissions to be reviewed and cleared steadily increased. But, beginning in 2012 and continuing through 2013, this timeframe stabilized.

2. In some cases, third-party reviews may get products to market quicker. According to Emergo, if a company’s device qualifies for a third-party review, this alternative route may pay off in the long run. “Yes, you’ll pay dearly for this luxury, but the additional cost might be offset by getting your device to market faster,” the report said.

3. Almost two out of threel 510(k) applications are cleared within six months. Although the FDA sets goals to review and respond to 510(k) submissions within 90 days, it is an uncommon occurrence thanks to the time required for you to respond to additional information (AI) requests. “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,”  Schorre concluded. Plan on the process taking closer to six months.

4. Different types of devices have different clearance times. While 510(k) submissions for all devices in 2013 took an average of 166 days to clear, Emergo’s research discovered that certain types of devices tend to clear quicker than others. Radiology devices were the quickest at 121 days, while dental devices took the longest, averaging 186 days to clear.

5. The number of 510(k) submissions cleared by the FDA per year has stayed stable. The study found that the FDA cleared more than 3,000 510(k) submissions each year since 2007, with the exception of 2010. Of these, almost 75 percent were traditional submissions, 22 percent were for modifications to existing 510(k)-cleared devices, and less than 4 percent were through the abbreviated process.

6. It may be too early to gauge the impact of the FDA Refuse to Accept policy. Beginning in 2013, the FDA implemented the Refuse to Accept (RTA) program, which rejects 510(k) submissions that do not meet the agency’s formatting and completeness requirements. Emergo’s study sought to evaluate how this new policy might impact overall 510(k) clearance trends, but there simply wasn’t enough data to reach any conclusions. “Last year was the first full year of full implementation, and ... we probably won’t see the true effect until we do an analysis of 2014 data,” Schorre reported.

Emergo Group is a U.S.-based medical device consultancy focused on studying regulation policies that affect medical device industries.