Consumer advocacy groups have recently stepped up efforts to publicly scrutinize FDA's 510(k) premarket notification process for devices and push for a higher burden of proof for getting the products to market.

FDA and industry stand firmly behind 510(k)s, which provide a regulatory pathway for many products to enter the market by showing "substantial equivalence" to an already marketed product, typically without the need for clinical trials. But groups including Public Citizen and the National Research Center for Women and Families are raising concerns and have clearly gotten the ear of some members of Congress.

Most prominently, a provision was inserted into a broad-based FDA bill passed by the House July 11 that charges the Government Accountability Office to study "the appropriate use" of the 510(k) process.

If the provision, which is not included in analogous Senate legislation, is made law, GAO will need to complete the study within a year and present the results to Congress. No additional steps are required, but some industry reps privately worry that Congress could see this as a first step to pushing for statutory changes to the 510(k) system, perhaps in conjunction with the next reauthorization of device user fees in 2012.

At a June 12 Energy and Commerce Health Subcommittee hearing, AdvaMed President Steve Ubl strongly defended 510(k)s as a valid and necessary regulatory tool in the device arena.

"Congress developed the premarket notification process to mirror the incremental innovation process that occurs in medical technology and where appropriate to help expedite incremental improvements in devices through the regulatory process," he told the panel. He said industry would support an independent analysis of 510(k)s, but that a device representative should be included in the study group to ensure that it is "fully informed and [to] include the perspectives of all potentially affected parties."

The premarket notification, or 510(k), classification process was instituted in 1976 when the agency first received broad authority to regulate medical devices. Substantial equivalence was addressed in the 1976 legislation and became codified in the 1990 Safe Medical Devices Act.

According to Heather Rosecrans, who heads the 510(k) policy unit within CDRH's Office of Device Evaluation, 90% of devices are cleared via 510(k) with others either going through the more rigorous PMA path or being deemed 510(k)-exempt. Clinical trials are required for about 10% of 510(k)s, Rosecrans said.

A device can be deemed substantially equivalent to a predicate device even if it has different technological characteristics, as long as it has the same intended use and does not raise new questions of safety and effectiveness and is at least as safe and effective as the predicate device.

"That's kind of a catch-22 because the vast majority of these products do not have clinical trials, so how could one say if their risks and benefits are the same?" NRCW President Diana Zuckerman asked during an interview with "The Gray Sheet".

510(k) Comparisons Criticized

The House provision asks GAO to evaluate how FDA comparatively assesses "technological characteristics such as device materials, principles of operations, and power sources" when considering products for 510(k) clearance.

The section reflects concerns raised in recent Congressional testimony by Zuckerman and Public Citizen's Peter Lurie that FDA is being overly broad in its interpretation of substantial equivalence and is too easily letting firms avoid PMA-caliber clinical trial requirements.

"To me, [what is] most worrisome about the 510(k) process is whether products that are made out of a new material or using a new technology can realistically be considered safe without clinical trials or a thorough review," Zuckerman said.

In testimony before the House Energy and Commerce Health Subcommittee June 12, she suggested that clinical trials be required for all medical devices that could potentially harm patients and that no implanted medical devices should be cleared through the 510(k) route.

She also suggested that the definition of "substantial equivalence" be reworked to limit 510(k) reviews to products that are substantially equivalent to a predicate device with respect to intended treatment, form, substance, mechanism, and function.

In May 22 testimony to the same panel, Lurie expressed concern that a substantial number of high-risk Class III devices are getting to market via 510(k).

New types of Class III devices generally require a PMA, but Class III devices can be cleared through a 510(k) if they are equivalent to devices that were legally marketed before 1976, unless FDA has published a requirement for manufacturers of that generic type of device to submit a PMA.

"The 510(k) process is a loophole that's swallowed the law," Lurie said in an interview. "Even among the Class III devices, the great majority of them go through 510(k), which I think is very different from what Congress intended in the first place.

"Certainly 510(k)s are there for Class I and Class II devices and we're not raising much of a question about that," he said. "It's the Class III devices that are the greatest concern."

"What we'd like to see come out of this are two things that are related to one another. One is the 510(k) process would be used less often and that more products would go through the PMA process, and the second is that this provision whereby you can have a device called substantially equivalent even without using the same technology would be scrapped," Lurie said.

Office of Device Evaluation Director Donna Bea Tillman defended the agency's use of 510(k)s and stressed the importance of balancing its mandate for least burdensome regulation of new technology and the protection of public health.

"I certainly think there have been cases when we have found things substantially equivalent, whereas some people might have viewed it as being a stretch," Tillman said in an interview. "But I am comfortable with decisions that we have made ... I am comfortable with where the program is. I do not see any need to change it."

- Ingrid Mezo (i.mezo@elsevier.com)

Scrutinizing 510(k)s: Critical Voices Get Heard In Congress

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