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.