Medical Device & Diagnostic Industry

From the _Editors
So Far, So Good for FDAAA
Some key provisions have yet to play out, but the most urgent device-related
parts of the FDA Amendments Act are working as intended one year later.

Sometimes, major FDA reform laws have unintended consequences that hamstring FDA or industry. Fortunately, that does not appear to be the case so far with the medical device provisions of the FDA Amendments Act of 2007 (FDAAA), which as of this fall has been in effect for one year. This is a testament to the negotiators from industry, FDA, and, yes, even Congress, which pieced together the medical device provisions of the law in a thorough way.

That was not an easy task, as the main focus on the law was on reforms related to the drug industry and how FDA evaluates drug products. The medical device provisions could have been an afterthought, but they weren’t. It is too early to call FDAAA an unqualified success for the device industry. But the early results have been good. Crucially, FDA and industry have been happy with the user-fee provision, which was the most important device-related reform.

“Our real focus was on the user fees,” said Susan Alpert, Medtronic’s senior vice president and chief regulatory officer, who gave the device industry perspective on FDAAA as part of a panel at the Regulatory Affairs Professionals Society annual conference. “The first round was not easy to manage and did not do what we wanted.”

“Most device companies are small, with fewer than 50 employees, so the cost of a submission is an issue,” Alpert said. “And PMAs, which are the most expensive kind of submission, frequently do come from small companies. So one goal was that we needed predictability from a financial perspective.” To that end, submission fees are set at a fixed rate, and other predictable fees, such as those for site registrations and certain inspections, have been put in place.

Also, the complex set of review goals the agency had to meet has now given way to one goal, concerning the final decision. That goal is to encourage more interaction between submitters and reviewers, Alpert said. “FDA now has greater visibility in the different parts of PMA work, and that is very important for industry,” she said.

Mark Leahey, executive director of the Medi-

cal Device Manufacturers Association, says his group’s members are mostly happy with the new review policies. “FDA has done a good job of reaching out to industry as far as what its expectations are for submissions,” he says. “The challenge is that there has been some inconsistency. The interactive review method has been embraced by some reviewers but not others. FDA is trying to get all reviewers onboard, and that is going to take some time.” The agency published a guidance document on interactive review in February.

The law has prompted much work on use of devices in pediatric populations. “It requires us in certain cases to submit information about the pediatric populations that the product has the potential to be used on,” Alpert said. “But that information is not readily available. Not even the pediatric medical community knows. So there is an attempt to get at these data. We are working with NIH and FDA to identify ways [in which] this population can be appropriately described and [become] visible.” The law also requires FDA to submit to Congress a plan on how to support the development of pediatric devices. As of September, it was being drafted, she said.

The two biggest unknowns concern unique device identification and clinical trial registries. The law requires FDA to mandate a system in which a device can be tracked throughout the entire supply chain. But coming up with something that makes sense for all types of devices is a challenge. Yet, a proposed rule is coming soon, and it is one of CDRH’s biggest priorities, said CDRH director Daniel Schultz. The clinical trial provision requires the results of device trials to be posted on a government Web site effective October 2008. But, Alpert said, “we need guidance on this badly. Competition is a major issue. Finding a way to do this that does not reveal proprietary information is a challenge.”

Given the government’s track record, if stakeholders are saying one year out that a reform law is not an abject failure, that means something’s gone right. Let’s hope that holds up.