Why does FDA approve medical devices before they can be sold?
Before granting approval to manufacturers to sell their new devices, FDA science experts review the manufacturer’s data from investigational studies to see if: • the product does what it claims to do effectively, and • does not present any unreasonable risks to the patient. Where can I find more information about these products? Today there are many sources of information about medical devices and procedures including information on the internet from health care organizations, medical centers, and consumer organizations. One accurate source of information about the risks and benefits of the product is patient labeling prepared by the manufacturer and reviewed by FDA. Patient labeling is available for many of the devices listed on the Recently Approved Devices page Are all medical devices listed on the Recently Approved Devices page? No. Only devices that have gone through FDA’s premarket approval process and were approved after May 12, 2000 are listed on this page. The majority of medi
