Report: Longer 510(k) Clearance Times a Result of a More Rigorous FDA

The average time it takes to obtain 510(k) clearance for a medical device has risen steadily in recent years, possibly as a result of FDA becoming more rigorous in its reviews, according to a report by Emergo Group. The firm, which provides QA/QC and regulatory consulting services to medical device companies, analyzed five years of FDA 510(k) data earlier this month and gave MD+DI an exclusive first look at its findings.

The average number of days from submission to clearance increased every year from 2006 to 2010, rising 40% to 135 days, over the five-year period. In 2006, two-thirds of 510(k) submissions received clearance within 90 days. By 2010, just 42% were cleared in three months or less.

Longer wait times, the report suggests, could be the result of the agency looking closer at submitted data and asking more questions during the review process.

“FDA is coming back with more questions during the submission process, and there is an increasing tendency to require more clinical data,” says Chris Schorre, vice president of global marketing at Emergo Group. “Those are not necessarily bad things. They slow down the process, but they do result in more rigorous submissions.”

Schorre says he’s optimistic the trend of increasing wait times for clearance will not continue. Industry has complained that if the process does not become more predictable, firms will increasingly seek initial clearance for products in Europe and other overseas markets. Over the past year FDA has also publicly acknowledged the problem.

“We’re hopeful that FDA will find ways to address it, whether by fixing its staffing issues or simplifying [the 510(k) process],” Schorre says.

In the meantime, FDA’s third party review program could be an option for companies—especially smaller ones—trying to get their devices to market quicker. The report found that, over the five-year span, clearance times took on average less than half as long when obtained through a third party review as opposed to an internal FDA review. In 2010, clearance times averaged 138 days for internal FDA reviews and 73 days for third party reviews.

Yet, fewer than 10% of devices go through the third party review process. Schorre suggests that could be due to three factors: lack of awareness of the program, especially on the part of foreign submitters; the fact that the process is not suited for complex or high-risk products; and its relatively high cost compared with internal FDA reviews.

“You pay for it, but for some companies, getting to market 70 days earlier is big deal,” Schorre says.

The report also showed that the number of 510(k) clearances has decreased in recent years. There were 3,327 products cleared by the process in 2006 but less than 3,000 in 2010, with the data reflecting two straight years of decline from 2008 to 2010. 

Analyzing clearance time by device type found that pathology, immunology, obstetrics and gynecology, toxicology, and hematology devices took the longest to clear, at an average of more than 160 days. Radiology products, by comparison, breezed through the process in an average of 72 days.

Other findings include:

The entire report, titled “An Analysis of FDA 510(k) Data from 2006 through 2010,” is available from Emergo Group.

—Jamie Hartford

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