On January 15, 2009, the United States Government Accountability Office (GAO) issued a longawaited report1 titled “Medical Devices: FDA Should Take Steps to Ensure That High-Risk Device Types Are Approved through the Most Stringent Premarket Review Process.” The report criticizes the timeliness of the Food and Drug Administration’s (FDA) classification process for certain medical devices that were in commercial distribution prior to the Medical Device Amendments of 1976, as well as the agency’s use of the 510(k) Premarket Notification process for premarket review of some class III, higher risk, medical devices. The report urges the FDA to take steps to expeditiously issue regulations addressing all class III products that are currently reviewed via the 510(k) pathway.  

Background  

The Medical Device Amendments of 1976 amended the Federal Food, Drug, and Cosmetic Act (FDCA) to establish three classes of medical devices.2 Devices presenting the highest level of risk are classified as class III medical devices and generally require submission of a premarket approval (PMA) application providing evidence demonstrating the safety and effectiveness of the product prior to marketing. By comparison, lower risk devices are classified as class I or II products and are either exempt from premarket review by the agency or are subject to the 510(k) premarket notification process. Under the 510(k) process, a device can be cleared for marketing based on demonstration by the manufacturer that the device is substantially equivalent to one or more legally marketed “predicate” devices that do not require a PMA.  

Although most class III medical devices are subject to the PMA process, certain types of class III devices that were in commercial distribution prior to May 28, 1976, (referred to as “preamendment” class III devices) may be cleared using the 510(k) process until the FDA issues regulations requiring a PMA. However, the Safe Medical Devices Act of 1990 (SMDA)3 required the FDA to reexamine these preamendment class III devices and (1) determine whether they should be reclassified as class I or II products and (2) establish a schedule for promulgating regulations requiring PMA approval for those devices found not appropriate for regulation in class I or II. Under the SMDA the agency was required to determine the classification of these devices by December 1, 1995, and to establish the schedule for requiring a PMA submission within 12 months of determining that a device type should remain in class III.  

Following Congress’ enactment of the SMDA, the FDA published, in May of 1994, a Federal Register notice describing a strategy for implementing the SMDA requirements. The strategy divided 117 preamendment class III device types into 3 groups: (1) those devices (42 device types) that the FDA believed would remain in class III and require a PMA, (2) those devices (31 device types) that the FDA believed were strong candidates for reclassification into class I or II, and (3) those devices (44 device types) that the FDA believed were of very limited use and, therefore, would be unlikely to generate many viable PMAs or reclassification petitions. While the Federal Register notice provided a strategy for addressing the preamendment class III devices, it did not include a schedule for completion of the outlined process.  

By 2007 the requirements of the SMDA had not yet been fully addressed by the FDA. As part of the Food and Drug Administration Amendments Act of 2007, Congress directed the GAO to conduct a study of the FDA’s use of the 510(k) process.4 In addition to assessing the use of the 510(k) process for review of certain preamendment class III devices, Congress also asked the GAO to investigate the intended uses and technological characteristics of devices cleared through the 510(k) process and to evaluate the appropriate use of the 510(k) process.  

The GAO Report  

The GAO report summarizes the findings of the study requested by Congress. The principal focus of the report is criticism of the FDA’s failure to address in a timely manner the preamendments class III devices that continue to be reviewed through the 510(k) process.  

According to the report, as of October 2008, of the 117 preamendments class III device types identified by the FDA in 1994, 45 have been reclassified as class I or II products and 53 have been permanently classified in class III, requiring PMA approval. However, 19 device types have not yet been addressed by the agency and continue to allow 510(k) submissions for marketing clearance. Examples of device types falling into this category include semi-constrained artificial metal-on-metal hip joints, intra-aortic balloon and control systems, sorbent hemoperfusion systems, and external pacemaker pulse generators.  

The report concludes by noting that Congress had envisioned, at the time of the Medical Device Amendments of 1976, that all class III devices would eventually be required to undergo PMA review. However, according to the GAO’s analysis of the FDA’s premarket review statistics for fiscal years 2003 through 2007, a significant number of class III devices continue to be reviewed via the 510(k) process. The report goes on to explain that FDA officials have indicated a commitment on the part of the agency to address this issue, but have not provided a time frame for doing so. Noting that three decades have passed since the original passage of the Medical Device Amendments of 1976, the report states that it is imperative that the FDA take immediate steps to address the remaining class III devices that continue to allow for 510(k) review.  

Other Notable Observations  

The GAO report also describes the study results relating to the intended uses and technological characteristics of devices cleared through the 510(k) process. Specifically, the report describes an evaluation of a sample of class II and class III device 510(k) submissions between fiscal years 2005 and 2007. Based on this review, the report notes that approximately 1 percent of such submissions described an intended use that differed from legally marketed devices. Moreover, only 15 percent of the class II and class III submissions described new technological characteristics when compared to legally marketed devices. Of the class II and class III device submissions that the FDA ultimately cleared, none involved a new intended use and only 14 percent involved differing technological characteristics.  

The report provides previously unpublished detailed statistics, based on the GAO’s sampling, regarding the reasons 510(k) notices were not cleared. For example, considering all submitted 510(k) submissions, which reached a determination of “substantially equivalent” or “not substantially equivalent” over the relevant time period, only 0.7 percent were found “not substantially equivalent” because they presented new intended uses. Furthermore, only 0.5 percent were found “not substantially equivalent” because they presented new technological characteristics that were found to raise new questions of safety or effectiveness. The majority of “not substantially equivalent” decisions resulted from inadequate supporting data.  

Observations/Implications  

  • The FDA has committed to expeditiously addressing all remaining class III devices for which 510(k)s are currently permitted. All such devices must be either reclassified as class I or II products or the FDA will ultimately require a PMA for future marketing approval.  
  • Companies that currently market class III devices that were cleared using the 510(k) process should be aware that the FDA may begin requiring PMA submissions for product modifications consistent with the PMA regulations.
  • The FDA appears to be evaluating what processes will be used for addressing these issues. However, it is unclear whether the agency will determine that individualized notice and comment rulemaking is required for each device type or whether the FDA will attempt a more generalized regulation issuance approach.  
  • Although the report does not comment specifically on the appropriateness of the FDA’s use of the 510(k) process for class I and II products, the report may increase the likelihood of additional congressional scrutiny for the process generally in the months to come.