For Consumers

FDA-Approved Diabetes Devices

Most medical devices used to manage diabetes either measure or monitor glucose levels in the blood or urine or deliver insulin.  Some of these devices are regulated through the FDA’s Premarket approval process, which is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices.  An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device.  This database may be searched by a variety of fields and is updated on a monthly basis.

 

Instructions on how to use the PMA database to retrieve diabetes-related device information:
 
  • Open the PMA database.
  • In the 2nd box from the top, Trade Name, enter either Continuous Glucose Monitoring System (as much as allowed) or Insulin Pump. Leave all other boxes empty.
  • Located at the bottom right of the page, Click on the button marked “Search”
    Select a product on the list for additional information.
 
Additional information on the product classification like the type of device, definition, problems and recalls can be found by Clicking on the “Classification Name” of the product then follow the link to the next page where you Click on “Total Product Life Cycle (TPLC) Product Code Report.”
 

Page Last Updated: 08/28/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.