CDRH Adds 510(k) Goal to MDUFMA EffortsCDRH Adds 510(k) Goal to MDUFMA Efforts
Originally Published MDDI July 2006NEWS TRENDS Erik Swain
July 1, 2006
AdvaMed is optimistic about the new goal, according to Janet Trunzo.
CDRH will proceed with an optional goal regarding premarket notification (510(k)) submissions but not with one for premarket approval (PMA) submissions, officials announced at a meeting in May.
The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) gave CDRH the option of adding two goals for fiscal year 2007. One is to require a final decision for 80% of 510(k) applications in 90 days. The other is to require a final decision for 50% of PMA applications within 180 days.
The center must now write to Congress justifying its reasons for not adopting the PMA goal.
The decision to adopt the 510(k) goal was an easy one, said Donna-Bea Tillman, director of CDRH's Office of Device Evaluation, at the special meeting of stakeholders. The center is already meeting the goal, and it does not conflict with other goals, she said.
“In each fiscal year [since 2002], a greater percentage of 510(k) decisions have been made within 90 FDA days,” she said. “And predictability has increased. Previously, there was a gap between the lowest- and highest-performing branches. We have been able to close that gap because we standardized the 510(k) business process.”
The optional PMA goal, however, “is not simply an extension of [current PMA] goals,” she said. “We developed a business process to meet cycle and decision goals. Those mean we have to decide whether to send a Major Deficiency Letter earlier on. We have erred on the conservative side to meet cycle goals. So we are more likely to issue those letters. They have increased from 51% of PMA applications in FY 2002 to 68% in FY 2004. So that has decreased the number of final decisions that are reached within 180 days.”
Adding the 180-day requirement would be at odds with the current structure of PMA goals, she explained. “We think this would adversely affect the PMA program,” she said. Rather, CDRH and industry should look at overhauling the PMA goals when MDUFMA is reauthorized for FY 2008 and beyond.
Industry reaction was mixed. “We encourage FDA to meet all the goals, because it has the resources to do so,” said Janet Trunzo, AdvaMed's executive vice president for technology and regulatory affairs. “It has repeatedly committed to meet performance goals and has done a great job with them.”
Jori Frahler, director of federal affairs for the Medical Device Manufacturers Association, said CDRH has actually gotten worse at making final decisions on PMA applications quickly since MDUFMA came into effect and could use the incentives to get better.
Copyright ©2006 Medical Device & Diagnostic Industry
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