Published 9/1/2011
Manish K. Sethi, MD; Hassan R. Mir, MD; William T. Obremskey, MD, MPH; A. Alex Jahangir, MD

The evolution of medical device regulation in the United States

The IOM, the FDA, and the 510(k) process

On Sept. 23, 2009, the U.S. Food and Drug Administration (FDA) commissioned the Institute of Medicine (IOM) to study the premarket notification program—known as the 510(k) process—used to review and clear most medical devices marketed in the United States. After nearly 2 years of study, the IOM finally released its findings on July 29, 2011.

As orthopaedic surgeons, we rely heavily on the use of medical devices to treat patients with a variety of conditions—from fractures to arthritic joints. We are also faced with an ever expanding market of new products and technologies. For us, understanding the current debate around the medical device investigation process and the subsequent potential policy implications of the IOM report is critical.

Why the IOM?
The implications of the IOM report develop from its relationship to the FDA and the U.S. government. The IOM is an independent, nonprofit organization that works outside of government and provides nonpartisan advice to both government agencies and the private sector on issues relevant to health care within the United States.

Many of the studies conducted by the IOM are in response to requests from Congress or various government agencies, such as the FDA. The request to review the 510(k) premarket notification process came from politicians—including Sen. Charles Grassley (R-Iowa), then ranking member of the Senate Finance Committee, and Rep. Henry A. Waxman (D-Calif.), then chair of the House Energy and Commerce Committee. Industry leaders and consumer protection groups were also calling for a review of the 510(k) process.

Each group demonstrated unique concerns regarding the program: Congress desired more transparency in the decisions to clear medical devices, industry believed that the FDA had become risk averse in making decisions surrounding new devices, and consumer groups argued that the 510(k) process did not support consumers in making informed decisions on the safety and efficacy of medical devices.

What is the 510(k) process?
The requirement that manufacturers notify the FDA in advance of marketing a new product was established in 1938, under section 510(k) of the Federal Food, Drug, and Cosmetic Act. The premarket notification process known today as the 510(k) process was established in 1976 through the Medical Device Amendments Act and is designed to evaluate the substantial equivalence of a new device to an already marketed device
(Fig. 1).

Prior to 1976, the FDA did not have effective mechanisms in place to evaluate new products and wanted a better system to evaluate new devices without hampering innovation or excessively delaying access to new technologies. It is important to understand that the 510(k) process was not employed to determine the safety and effectiveness of a new device, but to determine its similarity to existing devices.

The FDA classifies medical devices into the following three categories according to their level of risk.

    • Class I devices present the lowest risk and are mostly exempt from either the 510(k) process or premarket review.

    • Class II devices pose some risk and include many orthopaedic implants. Most Class II devices can be marketed after submission of premarket notification through the 510(k) process. Essentially, in applying for clearance of a device under the 510(k) process, the device maker states its similarities to existing devices on the market and requests exemption from premarket evaluation.

    • Class III devices represent the highest level of risk and generally require premarket approval to support their safety and effectiveness before they may be marketed.

What did the IOM say?
In their report to the FDA, the IOM determined that the 510(k) program is “flawed based on its legislative foundation.” Instead of attempting to reform the program, the IOM concluded that the FDA should eliminate the 510(k) process and create a new program that would provide an integrated premarket and postmarket regulatory framework and offer a reasonable assurance of safety and effectiveness throughout the device life cycle.

The report, “Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years,” argues that Congress should enact legislation to establish a new regulatory framework for devices currently subject to review under the 510(k) program. (See “IOM recommendations on the 510(k) process,” in the online version of this article.)

The IOM’s conclusions surprised everyone—the FDA, consumers, and industry. Instead of being an outline on how to effectively reform the medical device evaluation process, the report argued that the 510(k) clearance process is inherently flawed and does not protect consumers in the current device market. The FDA has responded that it believes the 510(k) process is still very viable and will soon begin collecting comments on the report’s recommendations.

What does this mean for orthopaedic surgeons?
The IOM report clearly argues that the U.S. government and the FDA do not have an effective means of evaluating new medical devices and protecting consumers. Furthermore, the IOM adds a new component of evaluation by suggesting that postmarket evaluation be conducted throughout the life of a single device.

Although the FDA has publicly said that the agency will maintain the 510(k) process, it is safe to assume that a major overhaul of the program is likely to occur and that emerging medical technologies will be under increased surveillance. Orthopaedic surgeons should carefully follow this debate because the next few years will bring major changes to the way that medical devices are given access to the market place.

Disclosure information: Drs. Sethi, Mir, and Jahangir—no conflicts; Dr. Obremskey—Biomimetic.

Manish K. Sethi, MD, and A. Alex Jahangir, MD, have served as AAOS Washington Health Policy Fellows. They, along with Hassan R. Mir, MD, and William T. Obremskey, MD, MPH, are currently associated with the Vanderbilt Orthopaedic Institute Center for Health Policy.

Additional References:
IOM report: Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years

The 510(k) process: It’s not broken, so why “fix” it?

The 510(k) pathway: Changes may be coming

IOM recommendations on 510(k) process

    1. The Food and Drug Administration should obtain adequate information to inform the design of a new medical-device regulatory framework for Class II devices so that the current 510(k) process, in which the standard for clearance is substantial equivalence to previously cleared devices, can be replaced with an integrated premarket and postmarket regulatory framework that effectively provides a reasonable assurance of safety and effectiveness throughout the device life cycle. Once adequate information is available to design an appropriate medical-device regulatory framework, Congress should enact legislation to do so.

    2. The Food and Drug Administration should develop and implement a comprehensive strategy to collect, analyze, and act on medical-device postmarket performance information.

    3. The Food and Drug Administration should review its postmarket regulatory authorities for medical devices to identify existing limitations on their use and to determine how the limitations can be addressed.

    4. The Food and Drug Administration should investigate the viability of a modified de novo process as a mechanism for evaluating the safety and effectiveness of Class II devices.

    5. The Food and Drug Administration should develop and implement a program of continuous quality-improvement to track regulatory decisions on medical devices, identify potential process improvements in the medical device regulatory framework, and address emerging issues that affect decision-making.

    6. The Food and Drug Administration should commission an assessment to determine the effect of its regulatory process for Class II devices on facilitating or inhibiting innovation in the medical-device industry.

    7. The Food and Drug Administration should develop procedures that ensure the safety and effectiveness of software used in devices, software used as devices, and software used as a tool in producing devices.

    8. The Food and Drug Administration should promptly call for PMA applications for or reclassify Class III devices that remain eligible for 510(k) clearance.