Trade Groups See Threat to FDA Authority on Safety and EffectivenessTrade Groups See Threat to FDA Authority on Safety and Effectiveness

AdvaMed, the Medical Device Manufacturers Association, and other groups have filed a joint amicus brief in a lawsuit against Medtronic in order to argue that FDA should be the sole arbiter of the safety and effectiveness of medical devices. They say that if a product-liability case against Medtronic is allowed to go forward, state courts will have as much say as FDA does over whether a product is safe and effective.