NEJM Articles Argue to Sack FDA’s Device Clearance Process

Two commentaries published online August 10, 2011, ahead of print in the New England Journal of Medicine support the drive to eliminate the current US Food and Drug Administration (FDA) approval process for moderate-risk devices on the grounds that it is not up to the job of ensuring safety and efficacy.

Complaints about the 510(k) pathway came to the forefront on July 29 when the Institute of Medicine (IOM) released a full report on the topic, which had been compiled at the FDA’s request. Among other things, the IOM report calls for an entirely new regulatory framework. However, the extent of reform needed and the best way to implement any changes are a matter of debate.

In their article, NEJM executive editor Gregory D. Curfman, MD, and Archives of Internal Medicine editor Rita F. Redberg, MD, of the University of California, San Francisco (San Francisco, CA), agree that the IOM report “charts a path that is right for the future,” and specify steps that the FDA can take now.

Commentary by David R. Challoner, MD, and William W. Vodra, JD, who both served on the IOM Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process, meanwhile, delves into the ideas that shaped their report. “[T]he time has come for a forward-looking regulatory system, rather than one focused on past products,” they stress, noting that approximately one-third of all devices enter the market through 510(k) clearance.

Making the Case

Currently, the United States has a 2-pronged path toward device approval: Low- or intermediate-risk Class II devices, including most currently available DES, require demonstration of substantial equivalence to a predicate device via premarket notification or the 510(k) exemption process, while potentially high-risk Class III devices require reasonable assurance of safety and efficacy via the premarket approval pathway.

At the root of the problem is that the 510(k) framework “we use today was created 35 years ago in an era of much simpler and fewer devices,” Drs. Curfman and Redberg say. As such, “it is now outdated.”

IOM committee members Dr. Challoner, formerly of the University of Florida, Gainesville (Gainesville, FL), and Mr. Vodra agree that the system is inadequate. For example, merely asking for equivalence, rather than new clinical data, means that some devices may slip through the cracks without adequate evidence.

“Today, we have a system in which a new moderate-risk device can enter the market because it is substantially equivalent to another device that may have been cleared for marketing 2 years ago because its manufacturer showed that it was substantially equivalent to yet another device cleared in 2003, and so on, all the way back to a device that was being marketed when the law was enacted in 1976,” they explain. “But that original device might never have been assessed for safety or effectiveness, nor perhaps would any subsequent ones in the family tree.”

In addition, a new device does not need to match any single predecessor but rather can “be cleared by having various characteristics that are equivalent to individual traits of 2, 3, or more different previously cleared devices,” Dr. Challoner and Mr. Vodra conclude. “These prior devices do not even have to be marketed so there may be no real-world experience to provide a basis for assessing safety or effectiveness—even if we had a high-quality postmarketing surveillance system to capture this influence.”

Drs. Curfman and Redberg are more emphatic, pointing out that—despite the US Congress passing the Safe Medical Devices Act of 1990—even high-risk Class III devices can occasionally pass through the 510(k) pathway, sometimes with “disastrous outcomes.”

“[R]ushing untested and potentially dangerous medical devices into the marketplace carries serious risks,” they argue.

No Quick Fix

Based on these and other concerns, the IOM report concludes that the current 510(k) process “cannot be transformed” but rather “should be replaced with an integrated premarketing and postmarketing regulatory framework that gives reasonable assurance of safety and effectiveness throughout the device lifecycle,” Dr. Challoner and Mr. Vodra note.

The FDA still needs to obtain more information in order to design the new approval pathway, they say, pointing out that the IOM report lists attributes of an ideal process. It should:

• Be based on sound science
• Be clear, predictable, straightforward, and fair
• Be self-sustaining and self-improving
• Facilitate innovation that improves public health by making devices available in a timely manner and ensuring their safety and effectiveness throughout their lifecycle
• Apply relevant and appropriate regulatory authorities and standards throughout devices’ lifecycle to ensure safety and efficacy
• Be risk-based

Moreover, the agency “has also lacked a system for continuous quality improvement,” the IOM committee members write. “It should develop and implement a system to increase predictability, transparency, and consistency in all regulatory decisions for devices and to address emerging issues that affect decision making.”

Replacing the entire 510(k) system is indeed necessary, Drs. Curfman and Redberg agree. “Unfortunately, the FDA leadership has already suggested that it does not intend to implement this key recommendation of the report, although it may be open to other changes,” they point out. “As the best long-term improvements are contemplated, there are important steps that the agency can take now.”

Drs. Curfman and Redberg propose 3 main reforms:

• The use of 510(k) clearance for Class II devices should stop, as Congress made clear 20 years ago
• The use of multiple predicates in 510(k) clearance should be eliminated
• A formal system of postmarketing surveillance for medical devices should be put into place

“We strongly believe that, in the interest of advancing human health, patients must have easy access to innovative medical devices and that the approval process needs to be sensible and efficient,” they conclude. “But no one’s interest is served by putting defective medical devices onto the market where they cause harm to patients, waste health care dollars, and may kill jobs when they are withdrawn.”

 

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Sources:
1. Challoner DR, Vodra WW. Medical devices and health: Creating a new regulatory framework for moderate-risk devices. N Engl J Med. 2011;Epub ahead of print.

2. Curfman GD, Redberg RF. Medical devices: Balancing regulation and innovation. N Engl J Med. 2011;Epub ahead or print.

3. Institute of Medicine. Medical devices and the public’s health: The FDA 510(k) clearance process at 35 years. Washington, DC: National Academies Press, 2011.

 

 

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