Product Index & Information
A medical device is:
To search for one of the products, use the Index of consumer topics.
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 manufacturers data from investigational studies to see if:
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 FDAs premarket approval process and were approved after May 12, 2000 are listed on this page. The majority of medical devices are cleared through the premarket notification process, a less rigorous process. Some devices are exempt from both processes. More information about FDAs regulatory processes is available at http://www.fda.gov/cdrh/consumer/geninfo.html
For more information on medical devices that were approved before May 12, 2000 or were cleared through the premarket notification process, please use our on-line search of the Premarket Approval (PMA) records or the on-line search of the Premarket Notification 510(k) records
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Center for Devices and Radiological Health / CDRH