FDA Evaluates its Premarket Approval Process for Devices

In response to increasing criticism toward the premarket approval process both from Members of Congress and the public who believe that the program may allow products on the market without adequate safety and effectiveness review, the U.S. Food and Drug Administration (FDA) announced on September 23, 2009 that the Agency has commissioned the Institute of Medicine (IOM) to perform an intensive review of the 510(k) program. 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 that is not subject to a Premarket Approval. Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalency claims.

The IOM study will look at two 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?

As part of the review, the IOM will hold two public workshops over the next nine months. A final report with conclusions and recommendations is due on March 2011.

While the IOM study is underway, the FDA will also convene an internal workgroup to evaluate and improve the consistency of the FDA decision making in the premarket process. The FDA said in a statement that medical technology has changed quickly in recent decades "making it an appropriate time ... to review the adequacy of the premarket notification program." The Agency also said that it is ready to implement the recommendations regarding the 510(k) process within months.

Premarket Approval Process Information

The 510(k) process was established under the Medical Device Amendments Act of 1976 with two goals:

• Make safe and effective devices available to consumers 
• Promote innovation in medical device industry

The FDA classifies medical devices into three categories according to their level of risk. Class I and Class II include devices such as adhesive bandages and wheelchairs. Most Class II devices and some Class I devices can be marketed after submission of premarket notifications—also called 510(k) applications—that support their substantial equivalence to legally marketed devices that do not require premarket approval. Under the 510k system, by arguing that their device is similar to products that have already been approved by the FDA, a company can speed up the approval process by simply giving the FDA 90 days notice of theintent to launch the product.

Class III devices, which include heart valves, pacemakers and implantable cardiac defibrillators (ICDs), represent the highest level of risk; this classification generally requires premarket approval to support their safety and effectiveness before they may be marketed.

For more information, please visit the FDA website