The medical device industry and the FDA are going back and forth over the establishment of a “total time goal” to track the agency’s performance in reviewing device submissions, according to minutes from meetings between the federal watchdog agency and industry representatives.
During a meeting held Sept. 13, the med-tech bloc proposed establishing the total time goal and keeping the performance goals enshrined in the Medical Device User Fee & Modernization Act, set to be re-authorized next year.
“The intent of the total time goal was to capture the anticipated efficiencies from many of the process improvements such as pre-submissions, refuse to file/refuse to accept, enhanced guidance, etc.,” according to the Sept. 13 minutes. “Both industry and FDA acknowledge that the total time goal is the outcome of program enhancements.”
Keeping the old goals “should allow for an easier transition for the agency,” according to the minutes, while the new goal would “provide an incentive for every application to be completed more quickly.”
The FDA then “expressed concerns that industry’s proposal did not address issues discussed previously in negotiations,” such as the need for separate goals for PMAs that are taken to an advisory panel, “the concern that maintaining the two-tier goal structure will make it more difficult to reduce total time, and the lack of agency control over the industry portion of total time to decision,” according to the minutes.
“The agency indicated its commitment to reducing total time to decision, as an important outcome for both Industry and the public health, but expressed concern that FDA could meet its part of the commitment and the total time could still increase,” according to the document. “The agency also indicated concern about potential unintended consequences of the proposed goal.”
By the time an Oct. 26 meeting rolled around, the two sides had moved closer on the issue, according to the minutes of that meeting.
“Industry stated that they are encouraged by the progress being made, which they attribute to willingness of both sides to listen to feedback from each other. Industry noted examples of areas where each side has compromised: While industry preferred two-tier goals, they agree to single-tier goals as FDA indicated this structure will be more manageable and consequently more successful,” according to the minutes. “Although FDA is concerned with risks associated with goals for total time to decision, they have worked with industry to develop a feasible shared total time goal structure. Industry stated that the number of outstanding issues is shrinking and indicated that both sides want to see a successful program under MDUFMA III.”
An industry counter-proposal slated to drop Oct. 31 was to have included “revised numbers associated with quantitative FDA time goals, but no changes to the goal structure,” according to the minutes.
“Industry agrees with the goal framework, which calls for progressive improvement over the first three years to reach targets, but industry indicated that they may need to be modified to meet industry’s expectations for continuous positive improvement in all submission types,” according to the document. “FDA explained that their proposal reflects consideration of the whole system, including areas industry indicated were most important and the degree of improvements that can be feasibly implemented in the first year.”
The negotiations are getting their share of attention on Capitol Hill. During a Senate hearing this week, Dr. Jeffrey Shuren, head of the FDA’s Center for Devices & Radiological Health, was grilled by Republicans over its requests for increased user fees.