In early February, the FDA and representatives from the medical device industry (Advanced Medical Technology Association, Medical Device Manufacturers Association, Medical Imaging and Technology Alliance) reached an agreement on recommendations for the third reauthorization of the Medical Device User Fee and Modernization Act.
The deal authorizes the FDA to collect $595 million in user fees, essentially doubling the amount.
In return the FDA has agreed to higher performance goals, including reviewing more applications more quickly, resulting in overall shorter review periods for 510(k) submissions. The FDA will also meet with an applicant midway through the process to ensure the company has enough time to respond to questions and requests. A third-party consulting firm will review the FDA’s procedures and recommend corrective actions if needed. The FDA must also publish regular metrics regarding review times, withdrawal rates, clearances, and other measurements of its medical device pathways. There is also a section of the agreement dubbed “Leave No Submission Behind” which requires the FDA to contact device-makers when their applications fall behind the ideal time frame.
The higher fees allow the FDA to hire over 200 full-time equivalent workers by the end of the five-year program. The $595 million will support about 35 percent of the FDA’s review activities (currently fees cover 20 percent).
According to the Massachusetts Biotechnology Council (MassBio), the FDA has agreed to time frames for pre-market approval applications and 510(k) submissions that will consider total review time in calendar days in addition to “FDA days.”
“‘FDA days’ measure how many working days the agency has spent on a particular application, but do not include periods when the agency has ‘stopped the clock’ by, for example, putting the ball back in the device maker’s court by asking for more information on an application,” says MassBio.
“By having a total-time goal that works in concert with an FDA-day goal we will, for the first time, be measuring—and performance will be tracked on—a total-time basis,” adds Stephen Ubl, president and CEO of AdvaMed. “We think that will have the net effect of reducing total review time, which is the most important measurement you can make.”
The industry wants to see an average total review time of 385 calendar days for PMAs and 124 calendar days for 510(k) applications by the final year of the deal.
“If this is tied to faster, better visibility and more efficiency, it’s worth its weight in gold,” says Thomas Gunderson, a Piper Jaffray & Co. analyst based inMinneapolis.
Even though many MDM leaders have applauded the deal, a few—such as Cook Medical president Kem Hawkins—are withholding praise until results start coming in.
“There is a long history of higher fees without a commensurate improvement in the time it takes to receive an FDA approval for a device that has been proven to save lives or reduce suffering,” he cautions.