By Ryan Hamilton, PhD

The process by which the FDA reviews medical devices has recently come under increasing criticism. Both consumer and manufacturing groups are frustrated with the slow pace and nature of the medical device review process.

In 1938, Congress first regulated medical products for safety and effectiveness, although at the time these were mainly drugs and not medical devices. In 1976 the FDA took sole responsibility to regulate the medical device industry in the US; two competing goals were the focus: to provide the public reasonable assurances of safe and effective medical devices and to avoid overregulation of the industry. The most recent reorganization of medical device regulation came in 2002 as the Medical Device Fee and Modernization Act (MDUFMA), which was interpreted by the FDA as a shift towards the least burdensome approach to medical device approval. The FDA, and more specifically, the Center for Radiological Health (CDRH), offers two paths to approval. First, is the Premarket Approval Process (PMA), typically used for products which support or sustain human life. This process is lengthy and intensive. The second path is the 510(k) approval process, which was designed for use with lower risk products as well as changes made to existing products, or those that are substantially equivalent to previously approved products. Regardless of the approval process, the federal Food Drug and Cosmetic Act requires reasonable assurance of safety and effectiveness before a product reaches the market.

Recently, the 510(k) process has become burdened beyond its design. In 2009, 90% of new medical devices were approved through 510(k) and the FDA received 4,000 submissions for approval. A 2011 Archives of Internal Medicine article, by Diana Zuckerman et al., reported that of the 113 Class I recalls of medical devices (Class I is the strictest recall of a product which has the potential to cause serious health problems), 71% were approved through 510(k) while only 19% through PMA.

Concerns about the 510(k) process, its evaluation of new devices, and increased prevalence of recalls led the FDA to take a two-pronged approach in September of 2009. The FDA conducted its own internal review of 510(k) to analyze what changes could be made to improve consistency in the program, and commissioned an independent study by the Institute of Medicine (IOM).

In August 2010, the FDA and the CDRH released a two-volume report which outlined proposed changes to the current 510(k) process. The goal of the FDA working group was to recommend reforms to the 510(k) process and make more effective use of science in regulatory decision making. The Journal of Medical Device Regulation reported on the FDA’s recommendations in a November 2010 special issue. The plan specified 25 specific actions to be taken, or at least begun, in 2011 in order to overhaul the 510(k) process. Overall the working group left the current regulatory framework intact, but with substantial revisions. Some of the proposed changes include streamlining of the ‘de novo’ process for low-risk devices, creation of a new class of device, IIb, to aid in categorization of moderate-risk devices, development of a network of scientific experts that can be called upon to help the agency evaluate new products as well as a senior science council aid in science-based decision making, and increased cooperation between submitters and scientific reviewers during presubmission. The updated regulatory framework set forth by the FDA puts an emphasis on the scientific evaluation of medical devices in hopes to avoid future recalls by approving innovative, safe products. In his congressional testimony, Dr. Jeffery Shuren stressed greater use of outside scientific experts, as well as better training for in-house reviewers, which will “provide greater clarity for industry through guidance and greater interactions about what we need from them to facilitate more efficient, predictable reviews.”

The second prong of the 510(k) process evaluation, the IOM report, was released in July 2011. Two questions were posed to evaluate the fate of 510(k): first, “Does the current 510(k) process protect patients optimally and promote innovation in support of public health?” and second, “If not, what legislative, regulatory, or administrative changes are recommended to achieve the goals of the 510(k) process optimally?” A major flaw (in two parts) in 510(k), noted by the IOM, is the substantial equivalency clause. First, as it has been used recently, a device can gain approval by citing substantial equivalence to devices that were approved prior to the current Medical Device Amendments and therefore were not subject to current standards. The FDA does not currently require proof of safety and effectiveness for predicate devices, which compounds the problem with this type of approval. Second, under the current system a device can apply for approval as a split predicate, those where a device claims equivalence to intended use of one predicate and the technology of another. The 510(k) designation was designed for this type of moderate-risk predicate device. This precipitated a letter to Dr. Jeffery Shuren, CDRH director, on behalf of the IOM, in which Dr. David Challoner concluded that the 510(k) approval process is not a determination that a device is safe and effective, and lacks legal basis to be a reliable pre-market screen for moderate-risk devices.

The IOM committee also outlined deficiencies in the current post-market surveillance, which could dramatically reduce the prevalence of large-scale recalls. Ultimately, the IOM report recommended the FDA abandon 510(k) and put in place an integrated premarket and post-market regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle (Institute of Medicine report, July 2011). Dr. Gregory Curfman, editor of the New England Journal of Medicine (NEJM), has also called for scrapping 510(k) in a recent NJEM article saying, “It is important to maintain and encourage innovation in medical devices. But true innovation requires that safety and effectiveness be proven by scientific study in clinical trials” (Curfman and Redberg, 2011).

Whatever the form that medical device reform ultimately takes, device makers have valid concerns about process as well as the end result. Medical device manufacturers worry that increased regulations in the new approval process would create uncertainty and stifle innovation. Mark Leahey, president of the Medical Device Manufacturers Association, said, “We remain concerned about efforts to overhaul a regulatory pathway that would create additional uncertainties and slow patient access to medical therapies.” Congressman Erik Paulsen, MN, disagreed with the IOM’s recommendation to scrap 510(k) altogether: “The medical technology industry is already facing unprecedented challenges – a job-stifling innovation tax and an increasingly out-of-touch FDA – and eliminating the 510(k) process would give Europe another leg up in competing for these made-in-America technologies, what the medical devices manufacturers need is consistency in the approval process, not more uncertainty.”

While the FDA aims to streamline the medical device approval process known as 510(k), others, such as the IOM, wonder if such changes are possible within the existing regulatory structure or if more radical changes are necessary – and device manufacturers and consumers are left uncertain as to the future of medical device regulation.

Read more about author, Ryan Hamilton, PhD


Curfman GD, Redberg RF. Medical devices – balancing regulation and innovation. N Engl J Med. August 10, 2011.

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.

Shuren, Jeffery, MD, JD. Statement to the House, Subcommittee on Oversight and Investigations Committee on Energy and Commerce. Regulatory Reform Series #5 – FDA Medical Device Regulation: Impact on American Patients, Innovation and Jobs, Hearing, July 20, 2011. Available at:; Accessesd: 8/14/11.

Zuckerman DM, Brown P, Nissen SE. Medical device recalls and the FDA aproval process. Arch Intern Med. 2011;171:1006-1011.

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