Medical Device Daily National Editor

LA QUINTA, California Daniel Schultz, MD, knows all about meeting impossible deadlines and dealing with budgetary restraints.

As director of FDA's Center for Devices and Radiological Health (CDRH), he's all too familiar with both. But Schultz also is a pragmatist of the first rank, clearly from the take-the-hand-you're-dealt school, so when he addressed members of the Advanced Medical Technology Association (AdvaMed; Washington) here during last week's annual meeting of the organization, there was no whining or gnashing of teeth.

Instead, as he does most every year, Shultz outlined for AdvaMed members gathered at the La Quinta Resort & Club his top half-dozen action items for 2008.

• First, and perhaps foremost, the agency will continue with the implementation of its push in the area of post-market analysis. "We have woken up to the fact that people expect expect to know how [approved] devices perform," he said.
  The key for the agency, Schultz said, "Is that we want to be able to make good decisions, not fast decisions."
• A second important practice for the agency this year will be to continue with the implementation of what he called "MDUFMA II," which really was the FDA Revitalization Act (FDARA) of 2007, a compilation of bills that included a MDUFMA update. However, almost no one in Washington circles or beyond, for that matter — refers to FDARA, so MDUFMA II seemed like an appropriate enough designation.
  He told his industry-based audience: "We need to continue the work we've done together over the past five years ... [especially] continuing to improve the approval process."
  Schultz added: "We have a bill that works for the agency, works for industry and works for the American people. This new legislation allows us to plan" an appropriate pathway for the agency.
• A third point of emphasis this year will be continued implementation of IT solutions and the development of what he termed "enterprise solutions." He said, "We are an information agency," thus the need for continued emphasis on upgrading FDA's information technology capabilities.
• Schultz cited staff hiring and development activities as a fourth area of emphasis in 2008. "We need to optimize the potential of our individual employees to meet the needs of FDA," he said, adding, "We need to be able to hire good people and train them."
  He said another important development effort involves getting review staff out to appropriate meetings where they can learn more about what's happening within the device sector.
  Schultz also addressed the burgeoning problem of senior staff retirements and resignations, both those that already have taken place and a wave of such actions anticipated this year and beyond. "We are focusing on succession plans" to lessen the impact of such staff losses, he said.
  He got a big laugh from the audience when he talked about the relative youth of some of the recent agency hires to replace those who have been lost. "I know you get really nervous when you see FDA reviewers sitting in your waiting room and they look like they're about 12, but I want to assure you that they're really smart 12-year-olds."
  More seriously: "I've been amazed at the quality of people we're bringing in," Schultz said.
• A fifth area of CDRH attention within this year will be to continue existing efforts toward enhancing device research. "We need to be serious about research," he said, adding that the agency and industry "need to collaborate" on such matters, "to the extent that we can better define 'pre-competitive' spaces" and ... "act as a hub to try to answer some of these questions."
  Schultz said of the agency's independent research efforts thus far: "We're learning how to do this. We're dealing with some very complex questions, such as the performance of drug-eluting stents."
  Citing as another example of areas worthy of the agency's research focus the whole area of tissue engineering, that involves CDRH working with the Center for Biologics Evaluation and Research. (Jesse Goodman, MD, head of CBER, had been scheduled to be on the AdvaMed program with him but was unable to do so due to a family health issue.)
  Schultz said the two centers "are working very well together much better than in the past." He added: "The technologies [being brought to FDA for review] are forcing us to act as one agency."
  The heightened emphasis on in-agency research, Schultz said, is because "we're trying to understand where the industry is going, so that we can better design regulatory systems for three to five years out."
• A sixth key practice for CDRH in 2008 and the entire agency, for that matter is the move to the new White Oak campus, underway in stages. "We already have moved the labs, and the rest of the agency will complete the move in April and May of 2009."
  Responding to a question about improvements in the product approval process, Schultz said, "I'm an advocate for the 510(k) process," noting that "about 95% of all products go to market via the 510(k) route."
  FDA "needs to streamline those areas where we have a good understanding of [product equivalency]," he said.
  Schultz urged his audience, however, to "consider the other end of the spectrum those products that go through the 510(k) process but are really close to being PMA [pre-market approval], predicate devices."
  The agency and industry together "need to prove that 510(k) allows fast approvals, but is very safe."
  In response to another question, Schultz emphasized — as he does whenever the opportunity arises — that companies need to contact the agency almost from the moment an idea germinates.
  "We encourage early contact with the agency, giving us an idea of what you're thinking," he said. "You can hear our views, too early contact always is good."