Nearly 20 years after Congress directed the US Food and Drug Administration (FDA) to shore up its review process for medical devices, the agency in April asked the manufacturers of 25 types of high-risk devices to submit data proving that their products are safe and effective.
The FDA's request covers Class 3 devices, which pose the greatest risk to consumers from among 3 categories of medical devices. Class 1 devices include such low-risk items as tongue depressors; Class 2 devices such as thermometers pose medium risks. The Class 3 devices covered in the FDA's request for data include hip joints, spinal screws, an automated external defibrillator, an electroconvulsive therapy device, and a number of cardiac pacemaker parts.
The FDA's call for more information is the result of a General Accounting Office report issued in January that rebuked the FDA for failing to use a more stringent approval process . . . [Full Text of this Article]
