Published 10/1/2010
William M. Mihalko, MD, PhD, with Ammar Al-Saraf, Ali Al-Saraf; Katherine Sale

The 510(k) Process—It’s Not Broken, so Why “Fix” It?

What changing the 510(k) process means to orthopaedics

Chances are, if you implanted an orthopaedic device today, it arrived in the marketplace via the U.S. Food and Drug Administration’s (FDA) 510(k) program (Figure 1). Since 2003, more than 99 percent of all medical devices have been cleared through this pathway, compared to less than 1 percent approved through the premarket approval (PMA) process.

Under the Code of Federal Regulations, devices are classified depending on their type and whether they have previously approved predicates for comparison (Table 1). Most orthopaedic devices are Class II devices that obtain FDA clearance through the 510(k) pathway. It stands to reason that any changes to that pathway could have an immediate and significant impact on the availability of orthopaedic devices in the United States.

What’s behind the furor?
Beginning in 2008, several events drew the attention of the public and the media to the FDA’s process for reviewing products. FDA reviewers wrote to members of Congress alleging interference in the review process from FDA leadership and failure to adhere to internal processes. Congress responded with requests for more information about specific reviews and the Agency’s protocols.

Much of this communication centered on the review of one submission, ReGen Biologics Inc.’s application to market a device for use in treating injuries to the meniscus. The internal and external scrutiny of this clearance led to the product being reviewed again by the FDA’s Orthopaedic and Rehabilitative Devices Panel on March 23, 2010. Because 510(k) submissions are not routinely reviewed by Advisory Committee Panels, this move underscored the Agency’s efforts at transparency in the wake of Congressional scrutiny.

Additionally, a report by the U.S. Government Accountability Office (GAO), released in January 2009, concluded that the FDA should “take steps to issue regulations for class III device types currently allowed to enter the market via the 510(k) process by requiring PMAs or reclassifying them to a lower class.” Later that year, the House Energy and Commerce Committee held a hearing on whether current regulations were sufficient to ensure the safety and effectiveness of medical devices.

The FDA convened an internal working group in September 2009 to evaluate the 510(k) program and suggest changes to improve consistency, with an emphasis on actions that could be taken within the agency’s existing statutory authority. At the same time, the Institute of Medicine (IOM) was commissioned to complete an independent study of the program. The IOM study is focused on the following two key questions:

  • Does the current 510(k) process optimally protect patients and promote innovation in support of public health?
  • If not, what legislative, regulatory, or administrative changes are recommended to optimally achieve the goals of the 510(k) process?

Current status
The preliminary report of the FDA’s internal assessment was released on August 6, 2010, and the public comment period closed on October 4, 2010. The report included 70 recommendations—ranging from the provision of additional training and guidance for reviewers and submitters to the creation of a new subset of devices. This new “Class IIb” designation would be “an administrative designation to provide greater clarity regarding what submitters would generally be expected to provide for certain 510(k)s.” The IOM’s report is due in the summer of 2011.

AAOS involvement
Both the FDA and the IOM have held open public meetings to gather stakeholder input. On more than one occasion, AAOS members were the only physician association members in attendance.

Randall J. Lewis, MD, represented the Academy at the FDA meeting held Feb. 18, 2010, and at the IOM meeting on March 1. Kent Jason Lowry, MD, a member of the AAOS Biomedical Engineering (BME) Committee, delivered comments at the IOM meeting in June. As chair of the BME Committee, William M. Mihalko, MD, PhD, attended the final IOM panel on July 28.

In all cases, the AAOS urged both organizations to carefully assess the 510(k) program to identify specific areas in need of improvement and to allow the FDA to determine the appropriate administrative changes to optimize the effectiveness of its review processes.

The Academy’s position was validated by a presentation from Ralph F. Hall, JD, representing the University of Minnesota Law School. Mr. Hall compared Class I recalls of products cleared through the 510(k) program and those of products approved through the PMA pathway to determine if there was a significant difference in the risk to patients from 510(k) devices. Of nearly 20,000 510(k) approvals during the period 2004 to 2009, just 43 (0.22 percent) were subject to a Class I recall due to premarket issues. A similar percentage of devices approved through the PMA process (0.12 percent) were also subject to a Class I recall due to premarket issues during the same period.

According to Mr. Hall, these findings refute the claims of some groups that the PMA process is safer and better able to identify problems on a premarket basis. Since PMA products had a similar safety profile, he noted, existing protocols for the 510(k) process, when followed, effectively support public health.

Looking forward
The AAOS is preparing comments to the FDA, addressing the recommendations and the process of their review. Comments will also be submitted to the IOM this fall. Through the office of government relations, the AAOS has reached out to other specialty medicine societies to explore additional avenues for responding to the 510(k) reviews.

The AAOS is concerned about the relatively short comment period on the FDA report and the Agency’s plans to implement some of the recommendations prior to the completion of the IOM study. The AAOS is also interested in recommendations that call for the creation of new guidance from the FDA. Since the mandatory reports and guidance set forth in Medical Device User Fee and Modernization Act (MDUFMA) and the FDA Amendments Act of 2007, the Agency has lagged in its release of orthopaedic regulatory guidance documents. In fact, the FDA is currently more than 8 months late in submitting to Congress its MDUFMA performance report and was 7 months late in releasing its financial report.

The AAOS recognizes its responsibility, as a member of the larger healthcare community, to support the evaluation of the FDA’s 510(k) program and to participate in the development of strategies to improve the process for industry, surgeons, and, most importantly, patients. Historically, the AAOS has been supportive of increased funding for the FDA, to permit it to meet the expanding scope of its duties.

The AAOS acknowledges the challenges inherent in the evaluation of—and potential changes to—a program as large as the 510(k) program. For that reason, it is imperative that the FDA listen to stakeholders, reflect on the motivation for this review, and give thoughtful consideration to any changes that may impact patients’ access to medical devices.

William M. Mihalko, MD, PhD, is the chair of the AAOS Biomedical Engineering Committee and also serves on the Orthopaedic Device Forum. He can be reached at wmihalko@campbellclinic.com

Mr. Ammar Al-Saraf and Mr. Ali Al-Saraf, second year medical students at the University of Illinois-Chicago contributed to this article. Katherine Sale is the AAOS manager of biomedical research and regulation; she can be reached at sale@aaos.org

Device recalls
Recalls are actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm’s own initiative, by request of the US Food and Drug Administration (FDA), or by FDA order under statutory authority. The following are levels of recalls:

  • Class I recall: A situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
  • Class II recall: A situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or in which the probability of serious adverse health consequences is remote.
  • Class III recall: A situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
  • Market withdrawal: A situation that occurs when a product has a minor violation that would not be subject to FDA legal action. The firm removes the product from the market or corrects the violation. For example, a product removed from the market due to tampering, without evidence of manufacturing or distribution problems, would be a market withdrawal.
  • Medical device safety alert: Issued in situations where a medical device may present an unreasonable risk of substantial harm. In some cases, these situations also are considered recalls.

Source: http://www.fda.gov/Safety/Recalls/ucm165546.htm

Additional Links:

Review of the ReGen Menaflex

Meeting materials: FDA’s Orthopaedic and Rehabilitative Devices Panel

GAO report on 510(k) process (PDF)

House Committee on Energy and Commerce, June 18, 2009, hearing on medical devices

Institute of Medicine—Public Health Effectiveness of the FDA 510(k) Clearance Process

FDA preliminary report (PDF)

Presentation by Mr. Hall (PDF)

Letter from Congress to Secretary Sebelius on FDA’s ability to meet timely demands (PDF)