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January 2009 Regulatory Affairs Monthly Topic

Long-Awaited GAO Report Urges Action on Preamendments Devices

On January 15, 2009, the Government Accounting Office (“GAO”) issued a long-awaited report (1) evaluating the use of the 510(k) process by the Food and Drug Administration (“FDA” or the “Agency”).  As part of the FDA Amendments Act of 2007 (“FDAAA”), Congress required GAO to conduct the study to assess the use of the 510(k) premarket notification process for review of certain class III devices and to investigate devices cleared through the 510(k) process, to determine whether the process is being utilized appropriately.(2)  Contrary to widely held expectations, the report did not recommend that FDA subdivide its existing class II designation for moderate-risk devices.  Rather, the final report confined its criticism to the timeliness of FDA’s classification efforts in regard to certain devices that were legally marketed prior to the Medical Device Amendments of 1976, so-called “preamendment devices.”

Preamendment class III device were a particular focus of the report.  Although most high-risk class III medical devices are subject to the demanding premarket approval (“PMA”) process, preamendment class III devices may be cleared through the 510(k) pathway until FDA issues regulations requiring a PMA.  Although FDA was required under the Safe Medical Devices Act of 1990 to either (1) reclassify preamendment class III devices into class I or II, or (2) issue regulations requiring PMA approval for the devices, GAO noted that 20 preamendment class III device types have not yet been addressed by the Agency.  These device types—which include semi-constrained artificial metal-on-metal hip joints, intra-aortic balloon and control systems, sorbent hemoperfusion systems, and external pacemaker pulse generators—can still be cleared through the 510(k) process.  Noting that three decades have passed since the Medical Device Amendments of 1976, GAO urged FDA to take immediate steps to address the remaining class III devices that continue to be eligible for 510(k) review.

GAO also investigated the intended use, indications for use, and technological characteristics of devices cleared through the 510(k) process, evaluating a sample of 510(k) submissions for class II and class III devices submitted between 2005 and 2007.  Industry stakeholders largely expected that this review would lead to a recommendation that FDA subdivide class II devices into groups of relatively lower- and higher- risk devices, given criticism by some that the 510(k) pathway was being inappropriately utilized to market complex devices that should be subject to PMA review.  Despite this criticism, GAO found that only about 1% of the reviewed 510(k) submissions described a new intended use or indications for use, and only 15% described “new” technological characteristics, when compared with legally marketed devices.  Of the 510(k) submissions that FDA ultimately cleared for market, none involved a new intended use and only 14% involved differing technological characteristics.  These results were likely behind the lack of any recommendation to subdivide the existing class II designation.  Also contrary to expectations, the report did not explore how FDA examines device materials, operating principles, and power sources in the context of establishing substantial equivalence for 510(k) submissions.

As a result of the report, FDA has committed to expeditiously addressing all remaining class III devices for which 510(k) review is currently permitted.  These devices will be reclassified into class I or class II, or PMA submissions will be required.  Thus, going forward, companies that currently market 510(k) cleared class III devices may be required to file PMA submissions, if FDA determines that their products should remain in class III.  Although the report does not comment specifically on the appropriateness of the 510(k) process for class I and II products, there is the possibility that aspects of this pathway may come under scrutiny in the months to come. 

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