The Minnesota Congressional delegation is concerned that the approval process of the Food and Drug Administration (FDA) undermines the country's medical device industry.
In a June 28 letter to FDA Commissioner Margaret Hamburg, MD, the Minnesota senators and representatives focused on the approval of investigational device exemptions (IDEs). These exemptions allow a new device to be used in a clinical study to collect safety and effectiveness data required to support an approval application. The delegation said the percentage of exemptions approved on the FDA's first review cycle has decreased from 76% in fiscal year 2000 to 56% in 2009. They added that this percentage dropped to 32% for 2010, a 43% 1-year decline.
Mitka M. Faster Device Review. JAMA. 2011;306(6):598. doi:10.1001/jama.2011.1121