FDA’s ability to implement its plan for rehabilitating the 510(k) process will directly impact the future of US medical technology innovation and US patients’ access to treatment. So says David Nexon, senior executive vice president and head of policy at AdvaMed. Nexon and AdvaMed’s Janet Trunzo, executive vice president for technology and regulatory affairs, spoke during a recent conference call. Nexon, who said AdvaMed was pleased with the way the implementation plan came out compared with the initial set of proposals, said it was important to put the plan “in the context of American competitiveness and patient access.”

Nexon referred to a report issued yesterday by PricewaterhouseCoppers (blog.medicaldesign.com/perspectives) that found that while the United States is currently number one in medical device innovation, “we are really slipping in all dimensions of leadership.” He added, “If you put this in perspective, 10 years ago, the US was the unchallenged leader in medical technology. Today we’re the challenged leader, and if we don’t take effective steps to address the problem, in 10 years we won’t be the leader at all,” noting that FDA is a critical part of that equation.

The PwC study found that the United States ranked 7 out of 9 competitor nations in the speed of regulatory review. “We are finding that the problems at FDA have really hindered innovation and investment in the medical device space, and most important, timely patient access to new treatments and cures.”

Nexon said the FDA’s 510(k) plan moves FDA in the right direction by recognizing that the 510(k) process is fundamentally sound, benefits American patients, and promotes innovation. “It generally appears that the changes should be targeted, have a corresponding health benefit, and support timely access to new treatments and cures,” he said.

But, he emphasized that the plan is only the first step in the process. The next step is a very complicated set of implementation steps, which includes Implementation of FDA 510(k) plan is critical at least eight guidances to be issued over the next year covering multiple topics. “How those [guidances] come out will make a big difference as to whether this continues to move FDA in the right direction,” said Nexon.

He said that AdvaMed supports the development of device-specific guidances because problems were not typically with the overall process in terms of FDA’s ability to protect patient safety. “Its record of being able to protect patient safety with this process is extraordinarily good, but certainly there are problems with specific device types, where changes in the regulations or standards might be appropriate,” he said. “We think that’s the right way to approach it.”

According to Nexon, many of the proposals have the potential to ensure that the plan improves the timeliness and the consistency of the review process. He said that AdvaMed wants to work with FDA to ensure that these particular changes are implemented in a way that is constructive, and that, over time, FDA addresses the broader concerns about the agency’s performance.

Trunzo said that reviewer training is one of the first actions that FDA will have fully implemented by summer 2011. FDA is establishing the Center Science Council, a group that will have a key role in the oversight of the review process to ensure consistency of reviews. AdvaMed supported the establishment of the council. “We feel that having that kind of oversight to look at the review decisions and ensure that there is consistency across branches and divisions is important to the entire process.”

Trunzo added that the 510(k) reform plan focuses on proposals that AdvaMed believes “will strengthen the already robust 510(k) program.” Those proposals, she said, include enhancing reviewer training, leveraging the use of external scientific experts, improving the consistency of reviews through the development of device-specific guidance documents, and streamlining the de novo process.

Continue on next page