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Flaws Found In FDA's High-Risk Medical Device Approval Process

Ruzanna Harutyunyan's picture

FDA continues to use a review and approval process created in May 1976 for high-risk medical devices that does not do enough to ensure that the products are safe and effective, according to a report released on Thursday by the Government Accountability Office, the AP/Denver Post reports. The report noted that at least 228 medical devices between 2003 and 2007 had been approved without a thorough evaluation, including about 24 high-risk devices such as heart defibrillators, artificial hip joints and electrodes for pacemakers (Alonso-Zaldivar, AP/Denver Post, 1/15).

FDA has "promised for decades that it would fix the problem," but has not, according to the New York Times. As a result, GAO stated in the report that "it is imperative that FDA take immediate steps" to resolve issues with the system (Harris, New York Times, 1/16). According to the AP/Post, the "root of the problem" appears to be that "FDA never fully carried out the intent of a decades-old change in the law" (AP/Denver Post, 1/15).

On May 28, 1976, Congress passed legislation that established a three-tiered classification of medical devices, which grouped medical devices based on their risk level to consumers and whether they were required to undergo the FDA-regulated 510(k) review process or a more rigorous premarket approval process, or PMA, USA Today reports. Medical devices were grouped in three classes: I, II or III. Devices under class I, such as tongue depressors and elastic bandages, were deemed to be the least risky.

Class II devices, including mercury thermometers and blood pressure cuffs, were designated as moderately risky (Rubin, USA Today, 1/16). Devices such as pacemakers and replacement coronary valves and other similar high-risk devices were grouped in class III (New York Times, 1/16). Class I and class II devices generally were required to undergo the 510(k) review process, while most class III items received the PMA review, according to USA Today. However, certain types of class III devices that had been approved for the U.S. market before May 28, 1976, were exempt from the PMA review and still could be cleared through the 510(k) process. Congress then allowed many class III products to undergo token reviews if they were deemed nearly identical to products approved before the 1976 rules.

However, Congress in 1990 enacted the Safe Medical Devices Act, a companion law to the original legislation that directed FDA to develop new regulations to reclassify all pre-1976 approved class III devices receiving class I and class II reviews (USA Today, 1/16). The new regulations mandated that all class III devices undergo the more rigorous PMA review process, even if they are similar to devices approved before May 28, 1976. Although FDA in 1995 planned to write the new rules, the GAO report stated, "When asked for their time frame for doing so, however, the [FDA] officials did not provide one" (New York Times, 1/16).

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The report noted that the agency has continued to approve new class III devices under the old rules and still had not amended them for 20 types of pre-1976 devices. "GAO recommends that FDA expeditiously take steps to issue regulations" for all such devices, the report stated (USA Today, 1/16). The report did not specify if any patients sustained injuries as a result of using devices that were approved under the old review process (AP/Denver Post, 1/15).

Karen Riley, a spokesperson for FDA, said the agency has been working to address the problems with its review process. Riley said, "In general we agree with the GAO's conclusions" to reclassify the 20 device types or require that they undergo the PMA review (Favole, Dow Jones, 1/15). She added that the agency is "considering legal and procedural options to accomplish this objective," but she did not specify a timeline for resolving the problem (AP/Denver Post, 1/15).

Implications of GAO Report

According to Dow Jones, the GAO report comes just a week after a group of nine scientists at FDA sent a letter to President-elect Barack Obama's transition team, citing concerns with the agency's approval process and urging the incoming administration to conduct an overhaul of the agency's "corrupted" scientific review process (Dow Jones, 1/15). Although "the allegations are a separate matter from concerns raised" in the GAO report, "taken together, they probably will raise the congressional scrutiny over FDA's medical devices branch," the AP/Post.

Rep. Frank Pallone (D-N.J.), chair of the House Energy and Commerce Health Subcommittee, said, "GAO's investigation confirms my concerns that the approval process for medical devices is woefully inadequate," adding, "For years, Congress has required high-risk medical devices to undergo stringent premarket review, but GAO's findings show that is simply not happening in every case." Pallone said he plans to conduct hearings on the oversight processes of medical devices at FDA (AP/Denver Post, 1/15).

Reprinted with permission from kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, and sign up for email delivery at kaisernetwork.org/email . The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation. © 2007 Advisory Board Company and Kaiser Family Foundation. All rights reserved.