Under the provisions of the FDA Amendments Act of 2007(FDAAA), the Government Accountability Office (GAO; Washington, DC) is scheduled to issue a report to Congress on the "appropriate use" of FDA's 510(k) premarket notification process for the evaluation and approval of medical devices. The provision calling for such a report grew out of Congressional hearings during the Summer of 2007, before the bill was approved and signed into law by President Bush last September.

Several consumer groups, including Public Citizen (Washington, DC) and the National Research Center for Women and Families (NRC; Washington, DC) questioned the wisdom and validity of the 'substantially equivalent' predicate device concept, which is a core tenet of the 510(k) process.

Testifying before the health subcommittee of the House Committee on Energy and Commerce, in July 2007, NRC president Diana Zuckerman, PhD, called upon the legislators to seek a detailed analysis of how devices are evaluated and approved under the 510(k) protocol.

"Although the standard of 'substantially equivalent' for devices sounds almost like the standard for a generic drug, the reality is completely different," Zuckerman testified. "Many medical devices approved by the FDA through the 510(k) process are not like any medical devices already on the market, and are instead made of different materials, used for different purposes, use a different technology, or are otherwise 'new and different' rather than slightly improved."

Zuckerman and spokespersons for other consumer and pubic interest groups would like to see more rigorous evaluation of all medical devices, which would typically require greater use of clinical trials similar to medical products that are subject to FDA's premarket approval (PMA) process.

The 510(k) protocol was initially codified in the Medical Device Amendments of 1976, which significantly strengthened FDA's authority to regulate medical devices. The protocol has continued to evolve through agency guidance documents and legislation. The concept of substantial equivalence was acknowledged in the 1976 legislation and subsequently became codified in the Safe Medical Devices Act of 1990.

Concerned that FDA's 510(k) protocol is misunderstood, AdvaMed issued a report titled The 510(k) Process: The Key to Effective Device Regulation earlier this month. The organization described the report as a white paper that "outlines the history and evolution of FDA's 510(k) program from its inception with the Medical Device Amendments of 1976 to the present day, explains why the program is an appropriate and effective regulatory approach for the vast majority of medical devices, and dispels some common misconceptions about the program."

"The 510(k) process has a proven track record in ensuring the safety and effectiveness of medical technology while encouraging device development and meeting the needs of American patients, said Janet Trunzo, AdvaMed executive vice president of technology and regulatory affairs. "Unfortunately, this key regulatory process and the important role it plays in ensuring the integrity of medical devices in the U.S. market is not well understood."

AdvaMed says that 90% of all medical devices are evaluated and approved through the 510(k) process.

Mark Leahey, executive director of the Medical Device Manufacturers Association (MDMA; Washington, DC) said, "We vigorously support the 510(k) protocol. We believe it provides both a solid framework and flexibility for evaluating particular kinds of medical devices. FDA already has—and frequently exercises—its authority to require additional information and action steps before a device is approved via the 510(k) protocol. Of course, FDA always has the option of requiring a manufacturer to submit the device under the PMA standard."

The GAO report will review both 510(k) and PMA data over the five-year period of 2003–2007. In preparing the report, the agency met with representatives from AdvaMed, MDMA, FDA, and various other stakeholders. Although the report is due September 27, a GAO spokesperson has indicated that a written document will not be available at that time, but the agency will brief both the House Energy and Commerce Committee and Senate Health, Education, Labor and Pensions Committee on the salient findings.

The AdvaMed white paper, The 510(k) Process: The Key to Effective Device Regulation is available via www.advamed.org/MemberPortal/About/NewsRoom/NewsReleases/PR-81908-FDA510K.htm.

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