- FDA has launched a pilot program it hopes will make the 510(k) review program more efficient, cutting the time from submission to final decision to as little as 60 days.
- The program, called the Quality in 510(k) Review, or “Quik,” gives medical device manufacturers an alternative method for submitting those premarket notifications to FDA using the agency’s free eSubmitter software.
- The pilot will evaluate whether use of the eSubmitter software to format the 510(k) application will generate well-organized submissions that can be reviewed more efficiently, FDA said.
Compared to the agency’s premarket (PMA) approval process for novel devices, FDA’s less-stringent 510(k) pathway already affords manufacturers the opportunity for faster device approval with a claim of substantial equivalency to another device. The 510(k) process is intended for low- and moderate-risk devices whose characteristics are already understood.
Industry group AdvaMed says the process brings medical innovations to patients faster while ensuring safety and effectiveness, often involving hundreds or thousands of pages of documentation based on various forms of product testing.
However, critics of the 510(k) system contend the less-rigorous process is a factor in a continuing stream of device recalls. A recent analysis of foot and ankle device recalls, for example, found that 98 percent of the products recalled during a 10-year period were approved through the 510(k) process.
Such concerns have not slowed FDA’s push to accelerate the speed at which medical devices are brought to market in the United States. In a speech to an industry meeting earlier this month, FDA Commissioner Scott Gottlieb previewed the agency’s new approach to 510(k) submissions, saying the goal is to shorten the device center’s review times by as much as 30%, from a maximum of 90 days down to 60 days.
“This new approach is like a Turbo Tax for information submitted in 510(k)s,” Gottlieb said in his remarks.
The commissioner also said the streamlined electronic format will improve the consistency of the agency’s reviews and its overall productivity, freeing up staff to focus on evaluating applications for higher-risk devices and issues such as medical device cybersecurity.
But Adrienne Lenz, a senior medical device regulation expert at law firm Hyman, Phelps & McNamara, writes that sponsors may find it challenging to respond to FDA requests for more testing if the agency finds that data in an initial application are not sufficient. While certain applications may be able to quickly respond to FDA requests, for others "the ability of a 'Quick' 510(k) to reduce review times more broadly is unknown."
"It will be interesting to see if the pilot program results in more sponsors needing to submit a second 510(k) if the first cannot be cleared within the timeframe. In a current Traditional 510(k) review, FDA requests additional information around day 60 of their review and takes the remaining 30 days to review the additional information when submitted. If sponsors find that multiple 510(k)s are required, the timelines will be increased as instead of a 30 day review after they complete the additional work, it will now be a new 60 day review. Also, a second user fee will be necessary," Lenz writes in FDA Law Blog.
Products eligible for the Quik Review Program cannot be drug-device combinations, and the submission must be constructed with the eSubmitter template "non-In Vitro Diagnostic Device – 510(k).” FDA has provided a list of product codes for devices eligible for the program.