health
FDA regulation of medical devices "fundamentally flawed," IOM says
NEWS IN BRIEF — Posted Aug. 8, 2011
The process the Food and Drug Administration uses to approve new medical devices is "fundamentally flawed" because safety and efficacy data are not examined, according to an Institute of Medicine report released July 29.
The FDA review, known as the 510(k) process, requires the agency to approve medical devices that are "substantially equivalent" to devices already on the market. But that process leads to allowing the marketing of medical devices that may be dangerous or ineffective, and the FDA ought to come up with a way of testing new devices before approval, said the IOM's report (link).
In a statement, the FDA said it does not want to eliminate the 510(k) process but is considering ways to strengthen its review procedures. A trade group representing devicemakers said tougher approval criteria would do little to improve safety and would impede innovation.
Note: This item originally appeared at http://www.ama-assn.org/amednews/2011/08/08/hlbf0808.htm.
