Medical Device Daily Washington Editor

WASHINGTON — The Advanced Medical Technology Association (AdvaMed; Washington) held a session at its annual meeting titled "Demystifying the 510(k) Process," but the mood at the meeting was that if there's anything cryptic about the process, it's not where the process currently stands; it's where the process is headed.

Heather Rosecrans, director of the 510(k) staff at FDA's Center for Devices and Radiological Health, seemed to defend the 510(k) program at one point during her remarks, stating that the process is "not a rubber stamp or a fast-track approval" procedure. She also pointed out that regulations governing investigational device exemptions apply to clinical trials used to clear 510(k) devices as well as to approve PMA devices.

Regarding the report on the 510(k) program by the Government Accountability Office, Rosecrans said, "the report ... didn't really talk about problems with 510(k)s per se, but with class III devices that had not been reclassified." The Medical Device Amendments of 1976 didn't require immediate reclassification at the time the law was passed, she noted, stating further that FDA has "made significant progress" in the reclassification process. Prior to the GAO analysis, FDA had reclassified 122 of the original 149, Rosecrans said, although GAO undercounted the actual remaining number by seven because their review went back only five years.

Rosecrans reminded attendees that not all the original high-risk devices from 1976 are still in play. "Some of these have fallen into disuse" owing to technological obsolescence, she said, adding that FDA has nonetheless ordered firms to submit safety and efficacy data on all remaining 27. Firms have done so for all but two and the remaining two are in the works, she said.

Rosecrans also said that GAO and the Office of Inspector General at the Department of Health and Human Services have reviewed the program on several occasions, and she reminded attendees that the Institute of Medicine (IOM; Washington) "will hold two public workshops over the next few months" pursuant to the report FDA has commissioned from IOM.

The IOM report is expected in roughly 18 months and its delivery will more or less coincide with the next round of negotiations over the FDA user fee programs for the drug and device industries. This co-incidence is driving speculation that any legislation dealing with the 510(k) program may languish until 2011, when Congress could fold it into legislation reauthorizing the user fee programs.

However, Rosecrans cautioned that the agency's next steps will come sooner, including an effort "to tighten up under our existing authority" under the program. As for periodic reviews of the 510(k) program, she said, "I think everyone should expect that we will constantly review it," adding that the agency may conclude, "new administrative, regulatory and even legislative changes may be indicated."

Patricia Shrader, VP for corporate regulatory policy at Becton Dickinson Diagnostics (Franklin Lakes, New Jersey), also defended the 510(k) process, arguing, "for 30 years, the process has been used successfully by both industry and FDA to get a lot of good products to market" without undue safety or efficacy issues.

Shrader also hinted that industry was a bit late to the party on this issue. "I think it's fair to say that in 2006, when criticism started to pick up steam, a fair number of us were not too concerned," she remarked. However, those reports picked up intensity and frequency over time and have yet to abate despite that the GAO report "didn't find much to criticize" other than the need to examine the legacy devices from before 1976.

Shrader acknowledged that the flap over the Menaflex 510(k), a device owned by ReGen Biologics (Franklin Lakes, New Jersey), did little to help matters. She said that when she first picked up a copy of FDA's printed communiqu , she was initially "pretty heartened by the report," because of its attention to "how the political process got involved and drove the whole thing off track." She said her optimism held "until I got to page 15 and I read a section that extrapolated the findings from this one case to the entire process."

The report by IOM, Shrader said, "could be very helpful provided IOM gets the appropriate expertise," but she also stressed the importance that IOM "starts with a neutral position" and bears in mind that no drug or device review process is flawless.

Shrader noted that FDA is able to ask for as much data "as they feel they need" in any device application and commented, "the big question ... is are we going to have new legislation, new regulation or administrative changes?" She also raised the question of "why is the process misunderstood?" Part of the reason, she said, is that the phrase "substantial equivalence" is fuzzy because there are several components to the notion.

Still, "to get rid of that [process] and go into a process in which each device is reviewed as a stand-alone is a foolish endeavor," Shrader argued. She said industry is worried about lack of predictability and would like to see any changes imposed administratively rather than by legislation.

Shrader also confessed to some concern that FDA – and by implication Congress – will in the end "attack a gnat with a sledgehammer."

Mark McCarty, 703-268-5690