Medical Device Daily Washington Editor

ARLINGTON, Virginia – “Total product life cycle is what we’re all about,” Daniel Schultz, MD, director of the FDA’s Center for Devices and Radiological Health (CDRH), told attendees at this week’s 15th annual Device Submissions Workshop sponsored by the Advanced Medical Technology Association (AdvaMed; Washington).

Schultz said the center’s approach to device evaluation and review begins long before a device is submitted, and the evaluation does not end once approval is achieved.

In a briefing of the agency’s activities so far this year, the center director made it clear that CDRH is active in post-market review and follow-up, a sensitive topic now at the FDA following recent drug recalls and questions concerning post-approval review of devices.

“Providing good information leads to you [industry] providing good information, which works well for us, for you and, ultimately, the American public,” Schultz told a gathering at the Doubletree Hotel in Arlington.

“New technologies, no matter how great they are, continue to have problems once they go to market,” he said, and that the public expects information to be available “as soon as we have it – and that provides challenges both for FDA and industry.”

The center would be actively pursuing condition-of-approval studies, Schultz said, calling these “important for improving the credibility of the industry and the center.”

The studies, which look for additional clinical information to support safety and efficacy following a product application approval, often are recommended by FDA advisory panels as commitments on the part of device manufacturers

These studies, Schultz said, are “critical” in order to reach “the pre- and post-market balance that I think we all want.”

The control, tracking and follow-up of the condition-of-approval studies has been moved to the post-market group within the center, since that fits better with the group’s regular activities, he said.

Schultz said that post-market staff also would be involved earlier on in the premarket approval (PMA) application review process so that staffers are educated about the device in question, studies are properly designed, and they provide targeted information.

“And we are going to be following up,” he promised, adding that one of the center’s deficiencies is in providing immediate follow-up when post-market reports have not been submitted on time.

“You can expect that when you sign up for a condition-of-approval study that you will be getting letters from us, phone calls, etc., reminding you of your obligations as part of the approval process and responsibilities. And if it is not done, we intend to follow up quickly,” he said.

Schultz said the center is adapting to meet a changing workload, including an increase in combination products and devices that incorporate high-level, specialized technology.

Even with additional funding provided since 2003 through the Medical Device User Fee and Modernization Act (MDUFMA), he said the agency still has to make the most of “limited resources” and a continuing debate with the industry concerning the most effective use of user fee funds.

MDUFMA, he said, “is not something that provides us with unlimited resources and we must continue to manage those resources effectively.”

The MDUFMA program will reach a turning point when a decision must be made this fall on the compensating adjustor requirement in the legislation, Schultz said. Certain levels of funding are required from industry and the government, and the compensating adjustor allows and shortfalls to be carried over into the next fiscal year.

In the past, the FDA has advocated forgiving Congress of its funding shortfall – which since 1993 has been roughly 50% of what was promised. This solution has resulted in criticism from industry groups such as AdvaMed and the Medical Device Manufacturers Association (also Washington), which would like to see industry also forgiven of any shortfall in its fee contributions.

The user fee program is slated to sunset Oct. 1 if funding does not reach predetermined levels.

Budget cuts and fee collection shortfalls for FY03 and FY04 resulted in a $40 million deficit for the program. For FY05, the federal budget had requested that the program be fully funded this year. A change late in the budget cycle left another budget shortfall, though much smaller than the previous two years.

Because of fewer device submissions and a lack of Congressional funding, user fees have risen sharply.

AdvaMed and MDMA have expressed their desire to continue to support the program, but with changes. In addition to fixing the shortfall forgiveness, another suggested change has been a cap on fee increases.

“We have all heard a lot about the need for a cap,” Schultz said. “We are prepared and have been working with AdvaMed and with Congress to try and find a solution to this problem. But it is important to recognize that there are costs involved in having some kind of cap on resources.”

The effect of a cap would be significantly fewer numbers of staff devoted to review, especially because of federally mandated salary increases, he said.

“I am telling you this not because it is something we’re not willing to do – to sit down and find a solution to this problem – but we all need to be honest and aware that these kinds of changes in the program do have consequences,” he said. “The people we aren’t able to hire may not be in your specific area, but they could be.”

Donna-Bea Tillman, PhD, director of CDRH’s office of device evaluation, said that while the promise of MDUFMA is shorter review times, there is a bigger picture.

Critics say that fewer device submissions would seem to leave more resources for the center, but she argued that there is a long-term vision at work.

In addition to new hires in various specialties, there also is expanded guidance development for industry, better IT infrastructure, internal review of performance quality and electronic submissions that result from the increased funding.

“If MDUFMA continues to be funded, we can do a better job,” Tillman said, adding that even the expanded staff has been working at the limits of their abilities.

IT systems improvements “hold a lot of promise,” she said, calling the current system at CDRH “archaic.”

If funding remains flat, Tillman said the center would be able to meet goals but not be able to expand other programs.

And if MDUFMA were to go away? “None of us wants to think about that,” she said.