Medical Device Daily Washington Editor

WASHINGTON — The 510(k) program has fed tons of newspaper ink and blog pages of late, so it was only natural for the subject to come up during this year's joint session held by FDA and the Food and Drug Law Institute (FDLI; Washington).

One of the sessions held Thursday morning gave the 510(k) program a good thrashing out, but while few novel conclusions were drawn, the FDAer on the panel, Kate Cook, associate director for regulation and policy at the agency's Center for Devices and Radiological Health, told the audience to expect to see more 510(k) decisions going to advisory committees.

The trend toward advisory committee hearings for 510(k) filings was in place last year, with FDA holding at least two hearings, including a Dec. 3 meeting to discuss a diagnostic kit by Fujirebio Diagnostics (Malvern, Pennsylvania) and the Nov. 14 meeting reviewing the application for the Menaflex by ReGen Biologics (Medical Device Daily, Nov. 18, 2008).

Phillip Phillips, director of the medical device practice at the consulting firm of Becker & Associates (Washington), proctored the session, noting that the 510(k) program remains "the mainstay of the medical device program," accounting for "maybe even more than 90% of the devices that get to market."

Phillips argued that the 510(k) program is "one of the most misunderstood programs at the federal government today," noting that that criticisms "ebb and flow with the tides," mostly the political tides on Capitol Hill. "I will acknowledge that the 510(k) program can always be improved," Phillips said, but added nonetheless that he is "an advocate of the program," which he described as "a very rigorous program."

Diana Zuckerman, PhD, president of the National Research Center for Women and Families and a long-time critic of the 510(k) program, intimated that the program is inherently flawed because it fails to sort out high-risk devices that she said should not be cleared even if there is a well-traveled predicate. Even a PMA is only required to prove the device is "reasonably safe and reasonably effective," she remarked, adding that establishing safety and efficacy for the duration of a clinical trial does not prove that the device is safe in the long run.

Zuckerman said the episode of the ReNu moisture lock contact lens solution, made by Bausch & Lomb (Rochester, New York) is a case in point. She reminded the audience that the predicate "was not Bausch and Lomb's product" and that FDA conducted no inspection prior to clearance.

Noting that a host of eye infections followed the release of the product, which resulted in blindness in some cases, Zuckerman said that after the fact, an FDA inspection found problems with storage conditions, specifically storage temperatures, but the agency concluded that the "infections were due to changes in the formula, not violations" from the quality systems regulation. However, she cited another study, the authors of which saw the change in formula and storage temperatures, said to have hit 140 degrees Fahrenheit, as the culprits.

"What is an appropriate level of research to examine a new product to see if it's safe or effective?" she asked. "In public health it is not enough to do clinical trials. They must be peer-reviewed and published."

Zuckerman reminded the audience of several other product episodes, commenting: "The same small changes that might result in a product being better" or less expensive "also have the potential" to create problems. She said a clinical trial is not necessary for "the vast majority of medical devices" that are cleared as 510(k)s, but held ground on the view that FDA should more closely examine applications for "some devices that are implanted or are put in the human eye."

Cook took to the podium and posed the question of the day regarding the 510(k) program. "Is this an aging regulatory construct? I would propose it's a maturing regulatory construct," she said, stating that the process "involves the accrual of wisdom," which she said FDA is "using ... as we move forward today."

Roughly "10% of cleared 510(k)s include clinical data," Cook asserted, adding, "most include some performance data." Still, she said of Zuckerman's view, "We agree on something" in that "trials are needed for some, not others." Despite the concession, Cook held to the view that "a blanket position that data needs to be generated for all implants is not sustainable," and is often superfluous because "there's great familiarity with the product" on the part of reviewers.

"You should be aware that post-market studies can be required for many class II devices," Cook reminded the audience. As for popular notions regarding the 510(k) program, she asserted that it "is not a rubber stamp or a fast-track approval" and requires a substantial body of data in most instances. She pointed out that 510(k) applications can go to advisory panels, adding, "I think you'll see that more and more."

It may be a commonplace in industry that Congress is largely clueless as to the general features of 510(k) program, let alone its nuances, but the panel was divided on that score. Zuckerman said that her experience on Capitol Hill suggested that very few members of Congress "even knew the 510(k) program existed" before the latest dust-up.

However, another panelist, Mark Heller, a partner in the DC office of law firm Goodwin Procter who gave a brief overview of the history of the program, rebutted that view. He said he was on the staff of Sen. Ted Kennedy (D-Massachusetts) when Congress updated the Medical Device Amendments in 1990. Heller stated that in his view, "key congressmen and senators on the authorizing committees knew exactly what was going on" with 510(k)s."

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