Published 12/1/2009
Mary Ann Porucznik with Jeanie Kennedy

The 510(k) pathway: Changes may be coming

By Mary Ann Porucznik with Jeanie Kennedy

Investigation by IOM raises concerns about the future of the 510(k) pathway

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.

Established under the Medical Device Amendments of 1976, the 510(k) process has the following goals:

  • to make safe and effective devices available to consumers
  • to promote innovation in the medical device industry

The FDA contends that over the past three decades, technology and the medical device industry have changed dramatically, making it an appropriate time for the Center for Devices and Radiological Health (CDRH) and the FDA to review the adequacy of the premarket notification program in meeting these two goals.

As part of the study, which is anticipated to cost $1.3 million, the IOM will convene a committee to determine whether the current 510(k) process optimally protects patients and promotes innovation, and, if not, what legislative, regulatory, or administrative changes are recommended to achieve these goals. The IOM will issue its report in March 2011.

On a parallel track, the FDA has convened an internal task force to study the 510(k) process. Chaired by acting director Jeffrey Shuren, MD, JD, the task force is expected to release its assessment after the IOM recommendations are announced.

It’s a matter of risk
Medical devices are broadly defined. They can range from syringes and adhesive bandages to heart valves and knee implants. Recognizing this, the FDA has established three categories of devices (
Table 1). Devices are categorized according to the amount of risk posed to the patient.

Class I devices, which present the lowest risk and account for about 30 percent of all medical devices, are mostly exempt from either the 510(k) process or premarket review. According to the FDA, more than 4,000 new low-risk devices are exempt from premarket approval and are marketed each year.

Class II devices, which pose some risk, can usually be marketed after submission of premarket notifications—also called 510(k) applications—that support their substantial equivalence to legally marketed devices that do not require premarket approval. More than 90 percent of all medical devices that have been authorized to be marketed in the United States have been evaluated and classified through the 510(k) process.

Class III devices, representing the highest level of risk, generally require premarket approval (PMA) to support their safety and effectiveness before they may be marketed.

According to the FDA, devices that present a new intended use or include new technology that pre-sents new questions of safety or effectiveness may not be found substantially equivalent and do require premarket approval.

So, what’s the problem?
For more than 20 years, critics have pointed to inconsistencies in product reviews under the 510(k) process as problematic. Legislation has been passed to address these problems, but has failed to dissuade those who believe that the 510(k) program is an “easy way out” for manufacturers.

Recently, the integrity of the 510(k) process was questioned by two powerful Congressional committee chairs: the chair of the House Energy and Commerce Committee, Rep. Henry A. Waxman (D-Calif.) and the leading Republican on the Senate Finance Committee, Sen. Herb Grassley of Iowa. In a May 11, 2009, letter to Joshua M. Sharfstein, MD, then acting commissioner for the FDA, Rep. Waxman raised concerns about the advisory panel process, including the selection of advisory committee members. Newspaper reports at the time questioned whether the FDA actually conducts a full scientific review of the evidence or whether the agency ignores its own policies and procedures, yielding to political pressure to facilitate the marketing of unproven devices. An internal review conducted by the FDA found departures from processes, procedures, and practices within CDRH.

In light of these questions, some politicians are calling for a more stringent review of medical devices, one that more closely approximates the PMA process. The impact of such a move is being hotly debated.

According to William M. Mihalko, MD, PhD, chair of the AAOS Biomedical Engineering Committee, the 510(k) process is essential for orthopaedics. He points out that requiring all orthopaedic devices to go the PMA route would prolong the process and prevent devices from being approved or cleared for use. In 2007, for example, just 31 devices were approved under the PMA process. In contrast, more than 3,190 were approved under the 510(k) process (Fig. 1).

One of the reasons for inconsistencies in the 510(k) process is the lack of guidance documents and consensus standards. Guidance documents outline the processing, content, and evaluation of regulatory submissions; the design, production, manufacturing, and testing of regulated products; and the inspection and enforcement procedures. Standards are documented agreements containing technical specifications or other precise criteria to be used consistently as rules, guidelines, or definitions of characteristics, to ensure that materials, products, processes, and services are fit for their purpose.

“Guidance documents and standards help guide products through the FDA and to market,” said Dr. Mihalko. “The lack of guidance documents presents a challenging learning curve for reviewers, which is exacerbated by the high staff turnover in the Office of Device Evaluation.”

Although the FDA’s priority list included one orthopaedic guidance—on hip joint replacement systems—it had not been released as of Oct. 1, 2009. “The last externally initiated orthopaedic guidance document took 7 years to navigate the system,” said Dr. Mihalko.

“Without the 510(k) pathway, fewer orthopaedic devices will become available each year,” he continued. “Innovation may diminish, and even simple improvements in devices may become difficult to implement. The higher costs of clinical trials and performance testing under the PMA pathway could add significantly to device costs—certainly not something we want to see happen. And finally, if research and development activities relocate to markets with lesser regulatory burdens, the United States may lose its position as a leader in orthopaedic device technology.”

The AAOS role
The Academy’s Biomedical Engineering Committee works with standard-setting organizations such as the American Society for the Testing of Materials (ASTM) Committee on Medical and Surgical Materials and Devices and the International Standards Organization (ISO) to provide clinical input for consensus standards, which offset the need for government-imposed standards. For example, one of the current projects is an implant labeling standard, which was presented to the ASTM last month.

Label information on orthopaedic implants varies not only among different manufacturers, but also within a single manufacturer’s various products. (See “The impact of standardized labels,” AAOS Now, March 2009.) Inconsistencies in labeling increase the chances that the wrong type, size, or side implant may be opened or used. Opened but unused implants are typically discarded as waste under current federal and many hospital regulations. This increases healthcare costs; according to one recent study, an estimated $36 million in hip and knee arthroplasty components alone are wasted annually.

Standards for ultrahigh molecular weight polyethylene were also initiated by the orthopaedic community. These have now been approved by the ASTM and are being considered by the FDA for guidance document recognition.

In 2010, the AAOS will be working with the ASTM, the FDA, and industry on a symposium on mobile-bearing knee devices.

A. Seth Greenwald, DPhil Oxon, and Dr. Mihalko are among the cochairs for this symposium, which aims to document standards and publish a reporting document that supports a reclassification of mobile-bearing knee devices from Class III to Class II devices.

“It’s not sexy stuff,” admits Dr. Mihalko, “but the impact of regulatory activities on our specialty is significant. Our involvement in this arena is critical to ensuring clinical input in standards activities and to enabling the AAOS to have direct input in responding to government agency regulatory needs.”

Mary Ann Porucznik is managing editor of AAOS Now. She can be reached at porucznik@aaos.org

Jeanie Kennedy is manager of regulatory and government affairs in the AAOS office of government relations. She can be reached at kennedy@aaos.org

Online Links:

FDA Overview of Device Regulation

FDA internal report

FDA: Institute of Medicine to Study Premarket Clearance Process for Medical Devices

Review of the ReGen Menaflex

AdvaMed white paper on the 510(k) process (pdf)