Medical device industry officials defended the FDA at a recent Congressional hearing, calling the agency's oversight of their products “rigorous.”

“FDA has comprehensive authority to regulate medical devices through a combination of pre-market and post-market controls,” said Stephen Ubl, president of the Advanced Medical Technology Association. “It is important to remember that millions of Americans benefit from devices each year,” he said in a statement.

FDA spokeswoman Mary Long said the agency “takes its regulatory responsibilities over medical devices seriously” and would answer questions from lawmakers.

Commissioner Margaret Hamburg has vowed to examine the agency's use of a fast-track medical approval process that critics say is used to hurry through devices that need a more careful review.

The hearing featured a panel of medical industry experts, who told lawmakers FDA must toughen its approval process in order to better protect patients from injuries.

“Its standards, its procedures, and its rules don't meet modern needs of getting medical devices to those in need with confidence in their safety,” Representative Frank Pallone (D-NJ) said of the FDA's medical device review process. Another legislator called the approval process “broken.” And GAO (Government Accountability Office) Health Care Director Marcia Cross said FDA's inabilities “raise concerns” about the level of safety and effectiveness of medical devices.

The Congressional hearing focused on recent actions involving defective heart defibrillator wires and related devices that have been blamed for scores of patient deaths and injuries. Cardiologist William Maisel, founder and director of the nonprofit Medical Devices Safety Institute in Boston, said recent recalls of defibrillator wires and other devices raised questions about the FDA's ability to identify safety problems promptly.

In June, Minneapolis-based Medtronic Inc, announced the recall of 21,000 of its Kappa and Sigma series implantable pacemakers after the devices were found to contain faulty wiring that could cause the life-saving devices to malfunction. The company estimated there were more than 1.7 million of the devices in patients around the world.