Medical Device Daily Executive Editor

DANA POINT, California – No one who listened to Daniel Schultz, MD, director of the FDA's Center for Devices and Radiological Health (CDRH) during his appearance at last week's Advanced Medical Technology Association (AdvaMed; Washington) annual meeting could say he wasn't responsive to the views of the med-tech industry.

When a questioner followed up Schultz's presentation during the closing session of the meeting with a query about his view on the FDA and the Centers for Medicare & Medicaid Services (CMS; Baltimore) conducting parallel reviews of new devices for market approval and reimburse- ment, respectively, the CDRH head was both swift and decisive in his response.

"I'd be more than happy for us to do this," said Schultz.

What's more, he added, "If anyone [from industry] tries to do it and gets pushback [from the agency], I would like to know about it."

Noting that the idea of parallel product reviews by the two agencies that ultimately hold the commercialization fate of new med-tech products in their hands is part of former Health and Human Services Secretary Tommy Thompson's concept of "one HHS," Schultz told his questioner:

"I really think it is starting to take hold."

Still addressing the parallel review question, he said, "From our point of view, this is something we'd like to engage in. We'd need to decide the respective FDA and CMS areas of review [but] I think it's more of an issue for industry than for us."

Responding to another question relating to the FDA's Office of Combination Products, he said that the strengths of that fledgling office outweigh its weaknesses. "The most important point is that it's there."

Acknowledging that "there's a ways to go" in that area, Schultz reminded his audience that it's a very small operation thus far. "We're talking about five people," he said. "It's a very small group, but a good group, and," he said with only a slightly suppressed smile, "it's led by a device guy."

During his presentation, Schultz said that CDRH covers "an incredibly broad range of products that present us with scientific and regulatory challenges."

Among those challenges:

  • Evaluating smaller and smaller devices.
  • Combination drug/device products. "One of the most exciting things happening in this industry today . . . and one of the most challenging for us."
  • Combined diagnostic and therapeutic products.
  • Technology for children.
  • Technology he described as being something "we hope we never need," such as anthrax detection kits.
  • The proliferation of device companies, which he said numbered 10,000-plus in 1998, but now total more than 14,000.
  • The growing complexity of applications addressed by products coming out of those companies.

While CDRH has numerous priorities, initiatives and goals, Schultz said the center's No. 1 goal is meeting the Medical Device User Fees and Modernization Act (MDUFMA) goals for fiscal 2005.

As part of that, he cited the unit's Magnet for Excellence priority hiring program, with some 132 positions added since the advent of MDUFMA. "This has made an incredible difference to us and to you," he said.

He also cited the number of internal training programs being implemented to make sure existing staff keep up on technological developments, as well as the Medical Device Fellowship Program, which brings outside expertise into the agency as a supplement to permanent staff.

Schultz also said CDRH has "a lot of 'e' [for electronic] initiatives," including e-Consult to improve the flow of information back and forth between the agency and companies whose applications are under consideration.

He cited in particular the Turbo 510(k) program, which is being piloted in the area of in vitro diagnostics.

Among center initiatives, he noted the reorganization of the "RH" part of its program, radiological health staff in a push carried out last fall.

"We need to follow through on these items," Schultz said. "We need to make sure we balance our short-term and long-term efforts [in order to assure] a successful device program."

Also addressing the AdvaMed members in the Saturday morning session was Jesse Goodman, MD, director of the FDA's Center for Biological Evaluation and Research, who outlined some of the device aspects of that center's activities, including gene therapy delivery devices and pathogen inactivation programs.

Goodman singled out the center's Tissue Safety Frame-work, a set of donor suitability rules that he said will take effect in May.