Trade group cautiously upbeat on FDA plan

SAN JOSE -- Executives at a top trade group said they were generally upbeat about the plan the U.S. Food and Drug Administration laid out Wednesday for overhauling the 510(k) program used for most medical electronics devices. But it's too early to tell what impact the plan will have on the cost and time required for regulatory approvals in the U.S.

Yesterday, the FDA released a timetable for addressing 25 issues raised in the course of reports and public comment sessions in 2010. Many of the most controversial issues were deferred until the Institute of Medicine delivers in June a report commissioned by the FDA on the 510(k) program. Other issues will be addressed one at a time with guidance documents the FDA will release over the course of 2011.

"It's a long and complicated plan, but we are generally pleased with what came out compared to the original proposals," said David Nexon, senior executive vice president at the Advanced Medical Technology Association (AdvaMed).

The FDA ranked seven out of nine global agencies in speed of regulatory reviews in a report released by Price Waterhouse Coopers on Monday. "If we don’t take steps to address the problems, ten years from now we won't be a leader at all," Nexon said. "The new plan identifies a lot of the problems at the FDA, but it’s a long process and this is the beginning of the journey," he said.

From an industry perspective, the plan includes a mixed bag of actions. On the positive side, it calls for setting up a formal program to enhance FDA's staff levels and training, greater use of external experts and reviewers and better guidance on specific kinds of devices.

The plan also calls for simplifying the so-called de novo process for classifying lowest risk devices. It also aims to streamlining the IDE process for defining the kinds of tests products must undergo.

"IDEs has been a huge sore spot and drag on innovation in the U.S." said Janet Trunzo, executive vice president of technology and regulatory affairs at AdvaMed.

Industry also praised the FDA's plan to create a science council to track scientific developments and how they may impact the 510(k) process. "Having that kind of oversight to ensure consistency across FDA's branches and divisions is important to the industry," said Trunzo.

On the negative side for industry, the FDA plans to complete an analysis by November of the practice of pointing to multiple existing products as precedents for approving a new device. The so-called split-predicate approach is popular among medical electronics companies.

"We felt the split-predicate practice didn't call for an FDA action," said Nexon.

The FDA will defer until after the IOM report whether it will try to expand its authority to revoke 510(k) approvals. "That would require a statutory change [to FDA authority] and we object to that," said Trunzo.

The FDA also deferred to the IOM issues such as combining in its approvals the terms "intended use" and "indications of use." In addition, it deferred whether it should consider unintended or so-called "off-label" uses of a device when making approvals. Devices are sometimes widely used in clinical practice in ways not described to the FDA in the system's FDA approval request.

The IOM report is being prepared by a committee drawn from universities and other organizations. No industry members sit on that committee, but groups such as AdvaMed have addressed the committee in open hearings.

It remains to be seen what the report will conclude and how the FDA will respond to its recommendations.

Overall, industry is taking a wait-and-see approach to the FDA plan, given it has yet to deliver specific guidelines in any of the areas laid out in its action plan. "We need to focus on how the FDA will implement the plan because the details will be critical," said Trunzo.

"It's hard to tell [what impact the FDA plan will have on the approval process] because we don’t know the content of the guidance statements yet," said Nexon. "The FDA laid out many problems we agree should be addressed, but how well they address them remains to be seen," he said.