MOVERS AND SHAKERS 2006

When Daniel Schultz took over CDRH in 2004, he made beefing up postmarket surveillance a priority. The following year, problems with Guidant Corp.'s implantable cardioverter-defibrillators intensified the pressure on CDRH to hold industry to stricter standards on postmarket issues. Now, the center has come out with a plan for reform.

Most of the proposals, unveiled in November, focus on tightening up CDRH's own practices. For example, a top priority is setting up “cross-cutting product groups” to enhance communication between people from different offices who deal with the same products. But some will require extra effort from industry. Electronic reporting of adverse events may be mandated. Putting unique identifiers on most or all devices for better tracking is likely to happen. And annual reports for premarket approval (PMA) products might have to be better organized.

The recommendations should not come as a surprise to industry, says Bradley Thompson, a partner at Epstein, Becker & Green (Washington, DC).

“A lot of the proposed requirements and expectations have been around for a while,” he says. “The agency is doing its best to educate industry as to what its expectations are and what, in my mind, it should have been doing all along. It has given everyone an early warning that it is not pleased with the current level of postmarket surveillance. But the new recommendations will require rule making, which means the implementation is quite a while off in the future.”

Therefore, he says, device companies are not likely to make significant changes to their practices until they see how exactly the proposed changes will be implemented.

“The firms that have made changes to how they handle postmarket issues have done so because of issues that turned up in audits, not because of what the agency has been talking about,” he says.

The effect on industry will depend on the extent of the reforms, says Jonathan Kahan, partner at Hogan & Hartson, a Washington, DC, law firm. Radical change could bring costly new regulations, “but what I got from reading it is that the actual cost will be minimal in terms of cost and burden.”

The proposals to strengthen the Medical Device Reporting program should not be too costly to industry, he says. As for plans to reform the monitoring of postmarket clinical trials, “some in Congress are in the process of pushing an entirely new paradigm [for the drug industry], but I don't see that coming over to CDRH,” he says. “We should get a much more moderate, step-by-step approach.”

Nothing can be taken for granted, though, Kahan cautions. The Democrats now control Congress, and they are even more displeased with FDA's performance on postmarket issues than the Republicans were. “Everyone is in watchful, waiting mode, but my gut tells me it will be OK, that it will not blow up on the device industry like it did the drug industry.”

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