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.
- 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.