FDA Overview

Slide 5 of 30 

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•Medical products need to be proven safe and effective before they can be used by patients. The product categories covered by this requirement include:
•Medicines used for the treatment and prevention of disease,
•Biologics -- a product category that includes vaccines, blood products, biotechnology products and gene therapy -- and
•Medical Devices: FDA regulates all medical devices, from very simple items like tongue depressors or thermometers to very complex technologies such as heart pacemakers and dialysis machines. However, only the most complex medical devices are reviewed by the agency before marketing.