On Wednesday, Sen. Charles Grassley (R-Iowa) and Rep. Edward Markey (D-Mass.) said they will call for new rules requiring the FDA to collect more data on defibrillators and pacemakers. Critics have charged that not enough information is gathered from manufacturers, making it difficult for regulators to reliably assess the risks involved with specific models. Health plans and other providers have argued for a long time that they need access to the information in order to better compare makes and models. Manufacturers such as Medtronic and Guidant have resisted that argument, saying the performance data is proprietary. The announcement came two days before a meeting of leading cardiologists in Washington, DC, which is expected to feature debate on the topic.
- see this story [1] from The New York Times
Links:
[1] http://www.nytimes.com/2005/09/15/business/15device.html