Total review times for 510(k) submissions have increased by more than 55 percent since 2005 because of poor quality submissions by medical device manufacturers, the FDA said today.
The agency released internal analysis of increasing decision times, confirming industry’s claims that the total times for clearance through the 510(k) process have spiked dramatically in the last five years. Since 2005, the average decision time for a 510(k) submission has increased from 90 days in 05′ to 140 days in 2009, although the FDA says some data is still rolling in for the last two years and that this number could change.
FDA officials said that the quality of submissions made by manufacturers are mostly to blame for the increased times.
“Our analysis shows that that poor submission quality and sponsors’ failure to address deficiencies identified in first-round AI [additional information] Letters are major contributors to the increase in total review times,” officials wrote. “For example, 65% of the time FDA sent a second-round AI Letter because the sponsor failed to submit information requested in the first AI Letter.”
The FDA admitted that “inappropriate requests for additional information” were made by reviewers about 4 percent of the time.
The investigation included review of about 100 510(k) submissions received by the agency in Sept. 2010, as well as 100 additional information letters sent out by the agency over the same period. Of the submissions received, the FDA flagged most of the reviews for poor submission quality issues.
The FDA said 83 percent of the 510(k) submissions it studied had problems in one of the following areas: Inadequate device description, discrepancies throughout submission, problems with indications for use, failure to follow or otherwise address current guidance document(s) or recognized standards, or missing performance testing and required clinical data for certain devices.
Inadequate device description was the most common problem with about 52 percent, and unclear or improper indications of use got flagged about 26 percent of the time.
A study of the additional information letters revealed similar problems.
“Although these cohorts are unrelated, the distribution of deficiencies among them is strikingly similar,” the report stated. “Problems with submissions quality are contributing to an overall increase in review times. During 2009 and 2010, FDA received 4,103 and 3,880 510(k)s, respectively. Of those, 72% and 77%, respectively, received at least one AI Letter. As our analysis shows, the majority of AI Letters are sent due to poor quality submissions, including an inadequate or inconsistent device description and failure to follow current guidance or a national or international standard recognized by FDA.”
The report is sure to draw criticism from industry, which has claimed all along that the problems with increased decision times stem from the FDA “raising the bar” on the process by which the majority of medical devices come to market.
However, the agency has worked hard to de-bunk that. Dr. Jeffrey Shuren, director of the Center’s For Devices and Radiological Health recently told a gathering of medical device professionals at the MassDevice Big 100 Regional Roundtable that the agency hasn’t changed the playing field.
“There’s nothing we’re trying to do that raises the bar in terms of clinical data [on 510(k)’s],” he said.
He added that the agency is actively trying to understand the root causes of problems about predictability and transparency with the 510(k) program.
A long awaited review of the 510(k) review program by the Institute of Medicine is expected to be released in the next two weeks.