Little did Medtronic know that it would touch off a Congressional investigation when it recalled a key defibrillator component last week. The Committee on Oversight and Government Reform now is reviewing the FDA's procedures for approving heart-device components.
Committee Chairman Henry Waxman, a longtime U.S. Representative from California, is asking the agency for information on testing procedures for defibrillator leads. Meanwhile, the FDA said it would conduct its own internal review on whether to require lab testing before these products hit the market.
- check out the article from the New York Times