How Does FDA Device Approval Work?


The FDA makes sure new medical devices are safe and effective before they are used by health care providers and the public.

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DR. RODGERS: The U.S. Food and Drug Administration, or FDA, not only approves new drugs, they also support the development of new, safe, and effective medical devices.

Hi, I’m Dr. Griffin Rodgers, director of the National Institute of Diabetes and Digestive and Kidney Diseases at NIH.

My colleague, Captain Richardae Araojo, of the U.S. Food and Drug Administration explains:

MS. ARAOJO: Providing patients with access to safe medical devices that meet their health care needs remains a top FDA priority. Medical devices include everything from medical gloves to glucose meters, dialysis machines, certain mobile medical applications, and mechanical heart valves. The FDA makes sure new medical devices are safe and effective before they are used by health care professionals and the public. The FDA also monitors the safety and effectiveness of devices once they are available for use.

DR. RODGERS: Follow us on Twitter @NIDDKGov. This is Dr. Griffin Rodgers with the NIH.

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