The Institute of Medicine committee charged with recommending reforms to FDA's 510(k) clearance program will move the remainder of its efforts behind closed doors.

At the committee's final public meeting July 28, members said they will take a broad-based approach to contemplating potential changes to the program, including weighing whether the 510(k) law needs to be replaced outright.

In addition to recommending potential legislative changes, "it's within our charge to comment on the process itself, and whether it's the best method to protect patient health and promote innovation," committee chair David Challoner, VP for health affairs at the University of Florida, told reporters following the Washington, D.C., meeting.

The group will begin in early September to hash out its final recommendations and expects to publish a report on the 510(k) program - "its merits and its warts" - around May 2011, Challoner said.

The committee is anxiously awaiting FDA's own internal review of the 510(k) program, due out soon, he said (¹ Also see "CDRH Pre-Market Reform Proposals Expected Within Weeks" - Medtech Insight, 28 June, 2010.).

"It's absolutely going to inform our work," Challoner said. "We look forward to seeing that ASAP."

Final Meeting Focuses On Post-Market Oversight

The July 28 meeting focused on the post-market surveillance tools available to assess the longer-term safety and performance of 510(k) and other marketed devices.

Critics contend that because 510(k) devices generally require less pre-market testing, they pose a greater risk to public health once they reach the market.

For instance, public speakers at the prior IOM committee meetings on June 14 and March 1 (² Also see "IOM Committee Questions Adequacy Of Compliance Tools In 510(k) Program" - Medtech Insight, 21 June, 2010.) described health problems that occurred following implantation with a 510(k)-cleared surgical mesh, contending that the complications might have been avoided with more rigorous pre-market scrutiny.

But Ralph Hall, visiting professor at the University of Minnesota Law School, warned against giving too much weight to anecdotal experience.

"To the extent that there should or will be changes to the 510(k) program ... this needs to be driven by data and not opinion," said Hall, who also represents device firms as an attorney for Baker & Daniels.

Lessons Learned From 510(k) Recall Data

Hall and cardiologist William Maisel, Beth Israel Deaconess Medical Center, presented two studies of FDA recall data to gauge whether 510(k) products had more safety problems than others.

Maisel, who also heads the ³ Medical Device Safety Institute, compared data from FDA's 510(k) database (1996 to 2009) and recall database (2003 to 2009) to determine the recall rate per 510(k)-cleared product.

More than 48,000 510(k)s were cleared from 1996 to 2009, averaging about 3,000 clearances per year.

And from 2003 to 2009, the number of unique 510(k)s affected by a recall ranged from 400 to 500 devices, Maisel's data showed.

Most recalled 510(k)s were subject to only one recall during the time period (73.9%), though about 15% were subject to two recalls and almost 5% were recalled three times.

Recall rates were slightly higher in the 1-2 years following 510(k) clearance (about 1.6-1.8%), decreasing over time "as we learn more about the device," Maisel said.

Most 510(k) recalls (28.8%) were the result of manufacturing problems, such as inadequately controlled processes or problems with storage, packaging, labeling and equipment maintenance, as well as device design problems (28.4%), such as failure of the device to perform as intended despite meeting design specifications, the study showed.

Life-sustaining 510(k) devices and devices reviewed by FDA-accredited third parties were associated with a higher rate of recall, Maisel found, but implanted 510(k) devices were not linked to a significantly higher rate of recall.

Hall, meanwhile, analyzed Class I recalls from 2005 to 2009. Class I recalls are the most serious category, reserved for situations where there is a reasonable probability that use or exposure to a product will cause serious adverse health consequences or death.

He identified 118 unique Class I recalls, including 95 cleared and 16 PMA-approved devices.

About 48% of 510(k) recalls were due to pre-market issues, though the major pre-market problem was typically a design issue rather than an unidentified clinical risk, Hall found.

Thus, better oversight of a firm's quality system is more important than additional pre-market clinical data requirements, he stressed.

"QSR design controls [are] the best tool to address the recalls that we've seen," Hall said. "This data indicates [additional clinical studies] would have very little impact."

Are Surveillance Systems Adequate?

Meanwhile, FDA, the Veterans Health Administration and others discussed various tools to improve post-market surveillance of FDA-regulated products, including 510(k) devices.

FDA says it is looking toward greater collaboration with academia, as well as initiatives such as unique device identification and the Sentinel post-market safety surveillance network, to improve its current post-market tools.

This will help FDA identify and follow up on potential safety signals for marketed devices.

"Getting access to other data sources is going to be a big help for us," Susan Gardner, director of the FDA device center's Office of Surveillance and Biometrics, told the IOM committee.

But committee chair Challoner noted that post-market oversight is just "one small piece of the 510(k) problem."

And while "it's very easy to get anecdotes," the available FDA data does not paint a complete picture of the safety and effectiveness of 510(k) devices, he said.

Other data sources discussed at the meeting, such the VA's Cardiovascular Assessment Reporting and Tracking (CART) system, the National Cardiovascular Data Registries and the DELTA automated post-market surveillance project being carried out in Massachusetts hospitals, are encouraging, but "unfortunately they're very focused on one specific [product] field," he said.

- Jessica Bylander ( ⁴ j.bylander@elsevier.com )

Broad 510(k) Reform Still On The Table; IOM Panel Enters Closed-Door Phase

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