The U.S. Food and Drug Administration announced recently that it had commissioned the Institute of Medicine (IOM) to study the premarket notification program used to review and clear certain medical devices marketed in the United States. (Established in 1970 under the charter of the National Academy of Sciences, the Institute of Medicine is supposed to provide independent, objective, evidence-based advice to policymakers, health professionals, the private sector, and the public.)
The IOM study will examine a premarket notification program, also called the 510(k) process, for medical devices. While the IOM study is underway, the FDA’s Center for Devices and Radiological Health (CDRH) will apparently convene its own internal working group to evaluate and improve the consistency of FDA decision making in the 510(k) process.
The FDA classifies medical devices into three categories according to their level of risk. Class III devices (highest level of risk) generally require premarket approval to support their safety and effectiveness before they may be marketed. Class I and Class II devices pose lower risks and most Class II devices and some Class I devices can be marketed after submission of certain premarket notifications— the 510(k) applications. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective — that is, substantially equivalent — to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to pre-marketing approval. Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalency claims. Devices that present a new intended use or include new technology that presents new questions of safety or effectiveness may not be found substantially equivalent and thus may require premarket approval.
The 510(k) process was established under the Medical Device Amendments of 1976 with two goals: to make safe and effective devices available to consumers, and to promote innovation in the medical device industry. FDA says that during the past three decades, technology and the medical device industry have changed dramatically, making it an appropriate time for a review of the adequacy of the premarket notification program in meeting these two goals.
As part of the study, the IOM will convene a committee to answer two principal questions: Does the current 510(k) process optimally protect patients 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? The IOM review is supposed to be completed in 2011.
The study comes after the U.S. House Subcommittee on Health held hearings concerning medical devices last June. The Democratic majority said there is evidence of an approval system that is “broken” – – that its standards, its procedures and its rules don’t meet modern needs of getting medical devices to those in need with sufficient confidence in their safety. However, while critics point to a handful of device recall issues, more than 250,000 devices have gone through the 510(k) process.