Comments of Members of the Patient, Consumer, and Public Health Coalition FDA’s Center for Devices and Radiological Health 510(k) Clearance Process: Recommendations Proposed in Institute of Medicine

September 30, 2011

[Docket No. FDA-2011-N-0556]

Members of the Patient, Consumer, and Public Health Coalition support the Institute of Medicine’s (IOM) efforts to strengthen the 510(k) clearance process for medical devices, but believe that the concerns expressed by the IOM regarding the lack of proof of safety and efficacy can be addressed by substantially improving 510(k) criteria, policies, and implementation. We strongly encourage CDRH to incorporate the concerns of the IOM report into substantial efforts to improve the 510(k) process, and to better ensure the safety and effectiveness of implanted medical devices by requiring that they all be reviewed through the PMA process instead.

The following written comments complement oral statements made by several of our member groups at the September 16, 2011 FDA public meeting on the IOM report.

After the September meeting, we were deeply disappointed to learn FDA has “no current plans to implement” (1) the seven items the FDA referred to the IOM but which the IOM declined to comment on in its report. Many of these recommendations focus on safety issues. They include expanding the Center for Devices and Radiological Health’s (CDRH) authority to rescind a 510(k) clearance; its authority to consider off-label use when determining the intended use of a device; clarifying when a device should no longer be used as a predicate; and requiring postmarket surveillance studies as a condition of clearance for certain devices. We strongly urge FDA to stand by its mission of protecting the public health by implementing all of these seven recommendations as soon as possible.

Regarding the recommendations in the IOM report, we support the committee’s efforts to strengthen the 510(k) clearance process for medical devices by focusing “on strengthening the science base needed” (2) to more rigorously review medical devices. The IOM recommends that the FDA avoid spending its limited budget on trying to fix the 510(k) program. Instead, IOM said the program should be replaced because it “was not designed to determine whether a new device provides a reasonable assurance of safety and effectiveness…” (2) IOM notes that 510(k) clearance decisions are based on substantial equivalence to predicate devices—which often were not scientifically proven to be safe and effective.

Unfortunately, the FDA’s lack of resources makes it unrealistic for the Agency to quickly revamp the entire 510(k) process. Even if it were possible to do so, it would not be in the interest of public health to make no improvements in the meantime. We therefore recommend substantial incremental changes that are consistent with the concerns expressed by the IOM report, GAO reports, the CDRH task force recommendations noted above, as well as other reports and analyses. The FDA should implement the current laws regarding the 510(k) process and the PMA process in ways that emphasize the need for scientific evidence of safety and efficacy for all medical devices, and especially those that can directly or indirectly harm patients if they fail. We applaud Dr. Jeff Shuren’s statement that CDRH is “open to additional proposals and approaches for continued improvement of our device review programs.” (3)

We offer the following proposals to strengthen the medical device clearance process. The FDA needs to:

• Require scientific proof of safety and efficacy in clinical trials for all high-risk devices. All high-risk devices should go through the PMA process. We strongly support IOM recommendation 7-8, which states that the FDA should promptly call for PMA applications or reclassify Class III devices that are still cleared by the 510(k) process. The word “promptly is important because this issue has been dragging on for decades. CDRH is beginning to make progress on this issue and has recently issued a final rule requiring PMAs for a ventricular bypass (assist) device, pacemaker repair material, and a female condom. We urge to FDA to act as quickly as possible on all remaining preamendment Class III, 510(k) cleared devices.

• More accurately define “high-risk” devices. If a device can kill or seriously injure a patient if it fails, then it is a high-risk device. That would include almost all implanted devices. For example, implantable cardiac devices, artificial hips and knees, and surgical mesh should require PMAs.

• Add more stringent scientific data for many moderate risk devices to prove that they are safe and effective. The IOM noted that “FDA has not promulgated performance standards or special controls for the vast majority of types of Class II devices.” (2) It added, “In practice, the assessment of substantial equivalence generally does not require evidence of safety and effectiveness of a device.” (2)

• Consider a modified de novo process to clear Class II devices, as IOM recommended. We would support that IOM recommendation, but only if the de novo process could be revised to require robust scientific evidence that a Class II device is safe and effective. That would be an improvement to the current substantially equivalent process. However, as was noted in the 510(k) Working Group Preliminary Report and Recommendations (August 2010), the de novo process should not be used as a substitute for a PMA for higher-risk devices. It should not, for example, replace the PMA for implanted devices.

• Have clear regulations about when a device is no longer available as a predicate because of safety and effectiveness concerns. No recalled devices should be used as predicates. Also, multiple predicates should no longer be allowed, since they provide even less evidence of safety and effectiveness than single predicates.

• Require postmarket studies of 510(k) devices at the time of the 510(k) review, whenever needed to assure short-term or long-term safety or effectiveness. We strongly support IOM recommendations 7-2 and 7-3—regarding postmarket surveillance and regulatory authorities. This is an urgent need that FDA should address. We want to emphasize, however, that post-market safety studies are not an adequate substitute for pre-market clinical trials and scientific data, especially for implanted devices and other devices that can cause serious harm if they fail. We also urge CDRH to quickly implement a unique device identification system and national device registry, which would complement but not replace other types of postmarket surveillance studies. A UDI system and national registry would help to identify defective medical products so patients and doctors could be notified when those devices are recalled, and it would help CDRH flag safety signals such as the recent problems with metal-on-metal hips.

• Ensure that CDRH has the authority to conduct premarket and postmarket inspections of 510(k) devices, and uses that authority to protect the public health. Currently, FDA does not conduct pre-market inspections and only does postmarket inspections when problems have clearly arisen.

• Eliminate the third party review system. It has inherent conflicts of interest and is not cost-effective.

The device industry’s response to the IOM report has been disappointing. Industry tried to discredit the IOM by making critical comments about the report in the press even before the report was released. (4) The IOM committee is not the first to question the safety and effectiveness of devices cleared under the 510(k) process. The Government Accountability Office has issued several critical reports. For example, in a report from 1989—more than 20 years ago—the GAO criticized the 510(k) process. It stated, “FDA judged most medical devices to be substantially equivalent to pre-1976 devices and approved them without direct evidence supporting their safety and effectiveness.” (5) Several years ago, the U.S. Supreme Court affirmed the 11th Circuit Court’s conclusions that “[s]ince the §510(k) process is focused on equivalence, not safety, substantial equivalence determinations provide little protections to the public [emphasis in the original.]” (6)

The 510(k) process was intended to be used for moderate-risk devices, not high-risk devices. However, in “Medical Device Recalls and the FDA Approval Process,” published in the prestigious Archives of Internal Medicine, researchers found that four out of five medical devices recalled for life-threatening or very serious hazards were originally cleared by the 510(k) process or exempt from any review. These high-risk recalls involved 112.6 million devices from 2005-2009, and more than 345 million devices recalled as high risk in just the first six months of 2010. Subsequent analysis that combined high-risk with moderate risk recalls, such as hip replacement recalls requiring additional surgery, found that approximately 20% of medical devices are subsequently recalled because they can cause substantial harm.

Safety problems with implantable 510(k) devices are well-documented, from defective heart rings (annuloplasty rings), AEDs, surgical mesh, hip implants, and insulin infusion pumps, 510(k) cleared devices have caused needless pain and suffering to thousands of patients.

We strongly disagree with claims that all is well with the 510(k) process and that requiring better scientific evidence would reduce innovation or delay life-saving products from being available to patients. There is no evidence to support those claims. We agree with the IOM that “Information that would allow an understanding of the extent to which the 510(k) process either facilitates or inhibits innovation does not exist.” (2) The committee further stated “that innovation is not just change but a favorable change in the context of public health…” (2)

Members of the Patient, Consumer, and Public Health Coalition strongly disagree with the IOM report’s conclusion that the continued use of medical devices “provides at least a level of confidence in their safety and effectiveness.” (2) That same argument could have been used about the levies outside of New Orleans before hurricane Katrina struck. We hope that CDRH will not miss an opportunity to improve the medical device clearance process now—before disaster strikes.

The current 510(k) program can not assure the safety or efficacy of medical devices, but it can be substantially improved with incremental changes. If CDRH implements the above changes to the 510(k) process, then patients and the American public can be better assured of that their medical devices are reasonably safe and effective.


Breast Cancer Action
Cancer Prevention and Treatment Fund
Community Access National Network
Institute for Ethics & Emerging Technologies
Jacobs Institute of Women’s Health
National Consumers League
National Research Center for Women & Families
Our Bodies Ourselves
THE TMJ Association
Scientific Integrity Program, Union of Concerned Scientists
Woody Matters

For more information, contact Paul Brown at (202) 223-4000 or

(1) U.S. Food and Drug Administration (September 2011). Minutes from Negotiation Meeting on MDUFAIII Reauthorization, August 9, 2011.
(2) Institute of Medicine (2011). Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years. Washington, DC: The National Academies Press.
(3) Brown D, Aizenman NC (July 29, 2011) Advisory panel calls for revamping FDA approval process for medical devices. The Washington Post.
(4) Meier B (July 27, 2011). Study of Medical Device Rules Is Attacked, Unseen.
(5) U.S. Government Accountability Office (November 6, 1989). Medical Devices: The Public Health at Risk.
(6) Medtronic Inc v Lohr, 518 US 470 (1996).