FDA offers plans to improve 510(k) device clearance process, punts hard decisions to IOM

Editor’s  Note.  Leading articles on te 510(k) process for medical devices are posted herein because they are based upon the term “substantial equivalence”– the  same term applied to new tobacco products  in the recently enacted tobacco control legislation.

January 21, 2011 | Reed Miller


Silver Spring, MD – The FDA has outlined plans to make the 510(k) device clearance process “more predictable and smarter” but acceded to industry pressure by declining to act yet on some of the most controversial issues [1]. The news is being hailed by industry advocates as progress and booed by critics who call the plan “not forceful enough.”

Last year, an Institute of Medicine (IOM) committee and two FDA working groups began separate reviews of the 510(k) premarket notification process, which has been criticized by public-interest groups, some FDA staffers, and members of Congress as being too lax in allowing devices to enter the market without sufficient assurance of safety. Meanwhile, manufacturers and their lawyers have argued that the FDA’s application of the 510(k) rules is inconsistent and not transparent.

The agency issued an initial set of proposals for reforming its 510(k) program in August and, after considering the input from industry, medical societies, advocacy groups, and the general public, issued a 25-point action plan on January 19.

The key parts of the new action plan involve streamlining the so-called de novo review process for certain innovative, lower-risk medical devices; clarification of when manufacturers need to submit clinical data on their device; and the formation of a new Center Science Council of senior FDA experts to ensure “timely and consistent science-based decision making.”

“These actions will result in a smarter medical-device program that supports innovation, keeps jobs here at home, and brings important, safe, and effective technologies to patients quickly,” Dr Jeff Shuren, the director of the FDA’s Center for Devices and Radiological Health (CDRH), said during an announcement of the new plan.

The 510(k) process is the most common—and preferred—regulatory pathway for new medical devices to reach the US market. Unlike the premarket approval (PMA) process, which requires the manufacturer to show that the device is safe and effective, the 510(k) pathway usually requires only that the manufacturer demonstrate that the device is “substantially equivalent” to a “predicate” device or devices already on the market. The 510(k) process was set up for devices categorized as class II, those that are less dangerous and based on well-established technology. Substantial equivalence can often be proven with relatively little new clinical data, whereas the PMA process typically requires a major clinical trial.
More discussion for the most controversial proposals
Citing “significant concern” among stakeholders who submitted comments, the agency has decided to hold off on making any decisions on some of its working groups’ proposals until the IOM committee can provide further input on them.

Among the ideas referred to the IOM is a proposal to write a guidance that would define a subset of class II devices, to be known as class IIb, for which clinical information, manufacturing information, or postmarket data would typically be necessary to prove the devices are substantially equivalent to a predicate. Class IIb would be only an “administrative” distinction within the current device classification system established by law, the FDA task forces maintain in their recommendation report. “Potential candidates [for class IIb] may include some implantable, life-sustaining devices and/or life-supporting devices, which present greater risks than other class II device types,” the FDA states.

Some device manufacturers that submitted comments to the FDA on this proposal assert that class IIb would constitute an additional statutory class, which the agency does not have the legal authority to create. Other industry representatives support creating a subclass for a small group of higher-risk devices if guidance is provided for such devices. Consumer groups and third-party payers said they support the creation of class IIb if it leads to increased scrutiny for many devices that would otherwise just be classified as class II, but they oppose allowing devices that should be in class III—and subject to the full PMA process—to be put in this new category.

The Alliance of Specialty Medicine, which includes the Heart Rhythm Society and Society for Cardiovascular Angiography and Interventions, argued that there is currently no need for a new subclass within class II. “The assumption that implantable devices require more burdensome premarket requirements than nonimplantable devices is not based on evidence and will result in flawed policy,” the alliance told the FDA in written comments. “Class IIb, as proposed by FDA, will significantly increase the time and burden to bring new products to market . . . [which] will stall innovation in those product lines, leading to fewer devices brought to market for certain medical conditions.”

The agency has decided not to act on the proposal until it receives more input on it from the IOM.

The FDA also decided to ask the IOM for input on its task forces’ proposal to seek greater authority to require postmarket surveillance studies as a condition of 510(k) clearance for some devices, as it usually does with PMAs.

Some manufacturers believe that postmarket surveillance of devices as a condition of a 510(k) clearance could become overly burdensome, potentially stifling innovation and adoption of new technology. But some industry comments, as well as those from diverse outside groups, supported making postmarket surveillance a condition of coverage for some types of devices.

Some industry and healthcare professional groups argued that the FDA does not need more postmarket authority over 510(k)-cleared devices because the CDRH already has the authority to require postmarket studies by using “special controls,” the medical device reporting and the medical product safety network reporting programs. The FDA countered that currently its authority to require postmarket studies as a condition of a 510(k) clearance is limited by law to devices intended for the pediatric population.
Did the FDA cave?
Predictably, industry advocates generally praised the January 19 announcements while consumer advocates panned the agency for being too timid.

In a release [2], AdvaMed, the Washington-based trade association for the medical-device industry, says it is “pleased with FDA’s thoughtful analysis of comments by industry” and praises the plan for dropping or deferring to the IOM proposals that would “have significantly slowed patient access to new diagnostics and treatments and placed significant burdens on industry without corresponding health benefits.”

By contrast, consumer-advocate group Public Citizen argues that “by deferring several important, previously proposed FDA actions to a future report by the IOM—often because the device industry did not agree with these proposals when first issued by the FDA in August 2010—the FDA is not being forceful enough about improving the safety and effectiveness of new devices. [3]”

Public Citizen is particularly disappointed with the agency’s decision not to enact the class IIb proposal. The group supports that proposal “because the 510(k) process, as it is [currently] implemented, has failed to consistently protect the public health.”

During a conference call, CDRH director Shuren defended the decisions to refer the more controversial proposals to the IOM for further deliberation. He pointed out that industry was not the only constituency to question these proposals and that patient and provider groups also raised some concerns.

He maintained that the agency already has “the tools to protect the public” and that industry’s major concern is simply making the 510(k) process more transparent and predictable. For example, Shuren says the proposal to create a class IIb would have “no real impact on patient safety” and that it is “purely an administrative heuristic—putting a little more onus on the agency to better identify up front those devices that may require clinical data, manufacturing data, or a preclearance inspection. It has nothing to do with imposing additional requirements on manufacturers.”

He said that the FDA decided to ask the IOM for more input on the proposal to give the agency more authority to require condition-of-clearance studies because the IOM has already been looking very closely at the agency’s postmarket safety authority and held a public meeting focused on this issue.

He emphasized that referring a proposal for further counsel from the IOM does not mean the agency has decided that it will never implement that proposal.

Dr Rita Redberg (University of California, San Francisco) told heartwire that she was disappointed with the FDA’s decision not to act on the proposals for class IIb or the conditions-of-clearance studies. She is especially concerned that several cardiovascular professional societies opposed these proposals. “They say ‘it’s in the interest of patients,’ but I think it’s in the interest of patients for us to have good data that devices are safe and effective before we implant them in the body.” As editor of the Archives of Internal Medicine, Redberg has been especially critical of the FDA decision to clear new inferior vena cava (IVC) filter designs through the 510(k) process without seeing new clinical data. The FDA has received more than 900 reports of adverse events with these devices. “I’m worried about the implanted high-risk devices that are getting cleared without any data. There are lots of examples of stents, inferior vena cava filters, heart valves, that are [cleared through 510(k) but] not low risk.”

Redberg pointed out that although the IOM and FDA have solicited public comment, industry is by far the loudest voice in the comments and the most well-represented constituency at the public meetings. “It’s the nature of those meetings. Why would ‘the public’ take a day out of work to travel to a meeting that they have nothing invested in? So, for [the FDA] to say that they are responding to public comment is not accurate.”

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