The committee concludes that the 510(k) process lacks the legal basis to be a reliable premarket screen of the safety and effectiveness of moderate-risk devices and, furthermore, that it cannot be transformed into one.
You can click on the links on the page to the PDF and HTM reports to read the information, in depth.
http://www.iom.edu/reports/2011/medical ... years.aspx
Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years
Released: July 29, 2011
REPORT AT A GLANCE
Medical devices play a critical role in the health care of Americans. They can range from simple tools, such as tongue depressors and bandages, to complex or life-saving equipment, such as pacemakers, magnetic resonance imaging machines, and heart–lung machines. The Federal Food, Drug, and Cosmetic Act (FFDCA) requires a "reasonable assurance of safety and effectiveness" before a device can be marketed, and the U.S. Food and Drug Administration (FDA) is responsible for enforcing this requirement. Devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the 510(k) process, named for Section 510(k) of the FFDCA. Some policymakers and patients have expressed concern about the ability of the 510(k) process to ensure that medical devices on the market are safe and effective. Other policymakers and patients, as well as the medical-device industry, have asserted that the process has become too burdensome and time-consuming and that it is delaying important new medical devices from entering the market.
The FDA turned to the IOM to review the 510(k) process and answer two questions:
Does the current 510(k) process protect patients optimally and promote innovation in support of public health?
If not, what legislative, regulatory, or administrative changes are recommended to achieve the goals of the 510(k) process optimally
The IOM finds that the current 510(k) process is flawed based on its legislative foundation. Rather than continuing to modify the 35-year-old 510(k) process, the IOM concludes that the FDA’s finite resources would be better invested in developing an integrated premarket and postmarket regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle. The IOM outlines its criteria for this framework in the report.
No one listened, apparently, but not surprisingly:
The law states that a moderate-risk device that is substantially equivalent, or similar, to any previously 510(k)-cleared device or any device that was on the market when the Medical Device Amendments were enacted—referred to as a predicate device—can be cleared for marketing with some exceptions. When the FDA assesses the substantial equivalence of a device, it generally does not require evidence of safety or effectiveness; and when a device is found to be substantially equivalent to a predicate device, the new device is assumed to be as safe and effective as the predicate because of its similarity. Devices that were on the market before the Medical Device Amendments were never systematically assessed for safety and effectiveness—but they are being used as predicate devices. This leads the committee to find that 510(k) clearance is not a determination that the cleared device is safe or effective. The committee concludes that the 510(k) process lacks the legal basis to be a reliable premarket screen of the safety and effectiveness of moderate-risk devices and, furthermore, that it cannot be transformed into one.
Needless to say, none of this ever happened:
The committee finds that the current 510(k) process is flawed based on its legislative foundation. Rather than continuing to modify the 35-year-old 510(k) process, the committee concludes that the FDA’s finite resources would be better invested in developing an integrated premarket and postmarket regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle. This new framework should:
be based on sound science;
be clear, predictable, straightforward, and fair;
be self-sustaining and self-improving;
facilitate innovation that improves public health by making medical devices available in a timely manner and ensuring their safety and effectiveness throughout their lifecycle;
use relevant and appropriate regulatory authorities and standards throughout the life cycle of devices to ensure safety and effectiveness; and
Current information is not adequate to design a new framework, and the FDA should begin to obtain the needed information. Once adequate information is available to design an appropriate medical-device regulatory framework, Congress should enact legislation to do so. A new regulatory framework will benefit everyone—patients, healthcare providers, the medical device industry, payers, and the FDA.