FDA Commissions Premarket Notification Study
The U.S. Food and Drug Administration (FDA) has 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.
The premarket notification program, also called the 510(k) process, was established under the Medical Device Amendments of 1976 with two goals: make safe and effective devices available to consumers, and promote innovation in the device industry.
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?
IOM will hold two public workshops during the next nine months as part of its review. The $1.3 million study is slated for completion in 2011. For more information on the study, click here.