Questions about the adequacy of FDA's compliance and surveillance tools for 510(k) products were among those raised by an Institute of Medicine task force during its second public meeting to evaluate the pre-market clearance program.

The IOM committee met June 14-15 to discuss FDA's compliance and enforcement authorities regarding 510(k) devices, the impact of the FDA framework on device innovation and how the agency's regulatory system compares to that of other countries, among other topics.

The group was tasked by FDA to determine whether the 510(k) pathway, which allows certain new products to reach the market by showing "substantial equivalence" to similar, already marketed devices, "protects and promotes the public health" (¹ Also see "510(k) Predicate, Labeling Questions Arise At Institute Of Medicine Meeting" - Medtech Insight, 8 March, 2010.).

"There are concerns that the 510(k) process permits inadequately tested devices to reach the market," according to the committee's charge.

"We're not where we want to be," conceded Tim Ulatowski, director of the device center's compliance office. "We're constantly working to improve," he noted at the meeting.

More Guidance, Special Controls Needed - Report

Phil Phillips, president of the Phillips Consulting Group, presented highlights from a draft report that Phillips and former FDA staffer Larry Kessler, now chair of the health services department at the University of Washington's School of Public Health, prepared for the IOM committee.

The main strengths of the 510(k) program are its flexibility and ability to grant regulatory exemptions based on the risk of the product, their report noted.

The weaknesses of the 510(k) process include a lack of device-specific guidance and sufficient special controls to mitigate risk, as well as weak authorities to address issues with the safety and effectiveness of cleared devices, according to the report.

For example, unlike the pre-market approval (PMA) process for devices that are higher-risk, the 510(k) process does not give FDA the express authority to revisit and rescind market go-ahead.

Ulatowski and the committee did not discuss specifically whether FDA should be given the authority to revoke 510(k) clearances.

But FDA does have other authorities to oversee 510(k) products once they reach the market, Ulatowski noted.

For example, FDA conducts routine quality system surveillance inspections for Class II and III products, as well as "for cause" inspections for 510(k) products when the agency receives information about potential violations.

However, the agency does not have the authority to condition clearance decisions on successful good manufacturing practices inspections, except in special circumstances.

The agency also monitors websites and other materials, on the lookout for products being marketed without clearance or approval, or for off-label uses.

Further, FDA can detain violative 510(k) products at import, prompt or require recalls of 510(k) products, and sample or test products for problems, Ulatowski said.

Phillips emphasized that the 510(k) process, as is, is "sound," but said more resources are needed to determine whether companies are conforming to performance standards for 510(k) products, to conduct more inspections to ensure the quality of manufactured devices, and to develop additional product-specific guidance and special controls.

Former CDRH official David Feigal, VP-global regulatory at Amgen, agreed that guidance on all product types is needed.

While clinical evidence should be collected for all products, he added, such data should be gathered throughout the lifecycle of a product, not just in pre-market trials.

Speakers Discuss Impact On Innovation

The IOM committee acknowledged concerns by some that the current 510(k) process may be overly burdensome and inhibit innovation.

Josh Makower, founder and CEO of device company incubator ExploraMed, presented data on the financial costs of an unpredictable 510(k) clearance process.

According to Makower, a shifting regulatory paradigm for 510(k) products can increase the total costs of the regulatory and reimbursement process from an investment of about $73 million to about $126 million.

"These processes, if too difficult, will deter even the most talented innovators from entering the system," Makower said.

He urged the committee to consider whether the 510(k) system needs fundamental changes or just better management, including more product reviewers and better training.

"There are always going to be outliers, but absent evidence of a system failure, we need to be careful," Mark Leahey, president and CEO of the Medical Device Manufacturers Association, said in public comments to the IOM committee.

Leahey emphasized that new device tracking and data surveillance mechanisms on the horizon - namely the unique device identification system under development by FDA - will help paint a clearer picture of device performance and risk.

"With those types of mechanisms on the horizon, we have to make sure that we don't frontload the requirements on the pre-market side," he said.

Panel Raises Reimbursement Questions

The IOM committee also pointed out tensions between collecting enough evidence to get devices onto the market quickly versus collecting enough data to secure reimbursement.

"The real end-game is an intervention that has the buy-in or faith of the patients and physicians, as well as positive coverage and payment," noted IOM committee member Gary Dorfman, a radiology professor at Weill Cornell Medical College. "Usually that requires data."

"So, the very thing that accelerates innovation gets that [product] to the marketplace without availability," Dorfman cautioned.

But ExploraMed's Makower argued that earlier FDA clearance does not inhibit reimbursement.

"If you obtain your clearance with a straightforward trial, then at that point, you can do more studies," Makower said. "Little by little, you can develop a much broader data set."

Such trials are "a lot easier to do in a post-market situation," according to Makower, and in the meantime, firms would be able to make some profit on their cleared device.

U.S. Versus Global Regulatory Models

Finally, the committee discussed similarities and differences between global regulatory systems.

Speakers compared FDA's system to regulatory approaches in Europe, Japan, India and China, as well as the internationally harmonized regulatory model being developed by the Global Harmonization Task Force.

"New products and new technology can enter the marketplace in a more streamlined fashion with regulatory harmonization," Janet Trunzo, executive VP of technology and regulatory affairs at AdvaMed, said of the GHTF model.

The IOM committee agreed that a risk-based review system seems to be universally acceptable, but questioned whether the system should be divided into three risk categories - as in the U.S. - or four - as in European and other countries.

David Jefferys, senior VP at healthcare firm Eisai Europe, suggested that "it's right to differentiate between those [devices] in the middle section."

Trunzo, on the other hand, argued against making further distinctions. "There is always going to be variability within any class, whether you have a three-class or four-class system," she said, which is addressed by the reviewers who assign an appropriate level of oversight for each device.

"I think the three-class system here in the U.S. works very well," she emphasized. "I don't see any need to make changes in the classification."

IOM held its first information-gathering session on March 1, and the next public workshop is scheduled for July 28. The group is expected to draft an assessment of the 510(k) program by next summer. FDA's own internal assessment of the 510(k) program is expected out soon (² Also see "FDA Hints At Possible 510(k) Tweaks At Public Meeting" - Medtech Insight, 22 February, 2010.).

- Jessica Bylander ( ³ j.bylander@elsevier.com )

IOM Committee Questions Adequacy Of Compliance Tools In 510(k) Program

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