Correspondence

Modernizing Device Regulation

N Engl J Med 2010; 363:196-197July 8, 2010

Article

To the Editor:

The Perspective article by Garber (April 1 issue)1 overstates the impact of the Supreme Court's 2008 decision upholding federal preemption for medical-device companies. The 8-to-1 decision did not bestow immunity on medical devices approved by the Food and Drug Administration (FDA), as the article asserts, but merely confirmed long-standing legal precedent.

Patients have always been able to sue a manufacturer if a device is not manufactured or marketed according to FDA specifications, guidelines, or regulations. It is also important to note that preemption applies only to a narrow class of devices that account for only about 2% of devices approved annually.

Abolishing preemption will eliminate the FDA's primacy as the sole arbiter of the safety and effectiveness of medical devices and instead allow state courts and lay juries to make those important determinations. This could result in a patchwork of regulations in the 50 different states, and access to new treatment options could be limited, depending on where a patient lives. Replacing the judgment of FDA scientists with those of untrained juries would not be good for American patients.

Richard A. Samp, J.D.
Washington Legal Foundation, Washington, DC

Mr. Samp reports having filed an amicus brief in the U.S. Supreme Court case Riegel v. Medtronic on behalf of the Washington Legal Foundation.

No other potential conflict of interest relevant to this letter was reported.

1 References

1. 1

   Garber AM. Modernizing device regulation. N Engl J Med 2010;362:1161-1163
   Full Text | Web of Science | Medline

To the Editor:

Garber argues for a more stringent premarket regulatory process for medical devices. His case depends in part on several misunderstandings of the FDA's device review process.

Garber states that class I and II devices are considered “low risk,” whereas class III devices fall into a “high-risk” category. This is not correct. The FDA considers class II to encompass “moderate-risk” devices that require additional special controls, such as conformance to performance standards, labeling, patient registries, and training, to ensure safe and effective use. The FDA considers the potential risks associated with a device when determining the level of evidence needed for 510(k) clearance for that device. Some class II devices require clinical data for clearance — a requirement that is based on a risk assessment of the device design, the intended use, and the mechanism of action.

Garber also states that from 2003 to 2007, more class III devices were cleared through the 510(k) pathway than through an original premarket approval (PMA) process. This is not an appropriate comparison, because modifications to a 510(k)-cleared device are submitted as 510(k)s, whereas modifications to a PMA-approved device are submitted as PMA supplement applications. The appropriate assessment would compare the total number of 510(k) clearances (228) to the total number of original and supplemental PMA approvals (834). The FDA is currently evaluating the remaining class III 510(k) devices to determine whether they should be subject to PMAs or can be down-classified to class II.

In addition, Garber cites a recent study of weaknesses in clinical trials for device approval.1 This study has several serious flaws, including the impractical assumption that a randomized, double-blind, placebo-controlled study is the best design for all medical-device trials. The FDA has recently identified a different series of challenges facing device trials.2

The FDA is pursuing changes to premarket review of medical devices to promote technological innovation while maintaining high standards for device safety and effectiveness. We are improving the quality of clinical trials, including conducting full screening of study protocols, increasing study participation by women and pediatric and nonwhite populations, and issuing guidance that specifies the agency's expectations for the conduct of high-quality clinical studies in support of PMAs. The FDA has also undertaken an internal review and has commissioned the Institute of Medicine to conduct an assessment of the 510(k) program and to make recommendations for improvements.

Ryan M. Kretzer, M.D.
Christy L. Foreman, M.B.E.
Jeffrey Shuren, M.D., J.D.
Food and Drug Administration, Silver Spring, MD

No potential conflict of interest relevant to this letter was reported.

2 References

1. 1

   Dhruva SS, Bero LA, Redberg RF. Strength of study evidence examined by the FDA in premarket approval of cardiovascular devices. JAMA 2009;302:2679-2685[Erratum, JAMA 2010;303:422.]
   CrossRef | Web of Science | Medline

2. 2

   Kramer DB, Mallis E, Zuckerman BD, Zimmerman BA, Maisel WH. Premarket clinical evaluation of novel cardiovascular devices: quality analysis of premarket clinical studies submitted to the Food and Drug Administration 2000-2007. Am J Ther 2010;17:2-7
   CrossRef | Web of Science | Medline

Author/Editor Response

Predictions of far-reaching repercussions for medical-device litigation1 that were subsequently confirmed when “thousands of lawsuits against medical-device manufacturers [were] tossed out of court”2 contradict Samp's attempt to minimize the impact of the Supreme Court decision. The decision fueled the sentiment that the FDA needed to overhaul device-approval processes. I did not mean to imply that litigation in state courts is an attractive substitute for effective device regulation.

Kretzer and colleagues claim that I argued “for a more stringent premarket regulatory process” for medical devices. This misconception is at the heart of their comments. My Perspective article cited the Dhruva and Government Accountability Office studies that Kretzer and colleagues criticize, as well as the formation of the Institute of Medicine committee, as evidence of mounting pressure to tighten device approval. But I did not advocate more demanding preapproval requirements. Instead, I called for “a more comprehensive approach to the postapproval monitoring and analysis of the safety and effectiveness of medical devices.”

The characteristics of devices support an enhanced role for postapproval monitoring. Alternatives such as preapproval requirements for large or multiple randomized trials for every device and modification would be cumbersome and costly, seldom detecting adverse effects and benefits that occur infrequently or late. Furthermore, enhanced postapproval monitoring, when combined with greater flexibility in allowing changes in devices, could better accommodate incremental technological improvements.

The FDA authors correctly note that the need for special controls distinguishes class II devices. Class II is a heterogeneous category, encompassing low-risk devices such as air fluidized beds, powered heating pads, and wheeled stretchers, risks, such as intravascular catheters. Device classification has been a source of confusion and controversy. Even with dedicated regulatory staff, device manufacturers have encountered ambiguity and uncertainty in seeking an appropriate classification. That is why efforts by the FDA to clarify device classification are welcome.

Perhaps the FDA authors and I are in greater agreement than they acknowledge. Although they criticize what they see as an attempt to justify more stringent preapproval scrutiny, they do not comment on the recommendation to improve post-approval monitoring. As they review the use of the 510(k) exemption and other aspects of preapproval processes, they have an opportunity to consider device regulation more broadly. They might find that a greater emphasis on postapproval monitoring has the potential to protect the public better while facilitating device innovation.

Alan M. Garber, M.D., Ph.D.
Veterans Affairs Palo Alto Health Care System, Palo Alto, CA

Since publication of his article, the author reports no further potential conflict of interest.

2 References

1. 1

   Feder BJ. Medical device ruling redraws lines on lawsuits. New York Times. February 22, 2008:B1.
   

2. 2

   Curfman GD, Morrissey S, Drazen JM. The Medical Device Safety Act of 2009. N Engl J Med 2009;360:1550-1551
   Full Text | Web of Science | Medline