Studies testing the safety and/or effectiveness of a medical device are regulated by the Food and Drug Administration (FDA). Depending on the risk classification of the device being tested, a submission may be needed to the FDA prior to any human subjects research takes place. Additionally, specific requirements regarding the development, manufacturing, documentation, as well as other specific requirements may be needed to comply with the FDA regulations and law. Therefore, we offer support to Georgia Tech faculty, students, and staff in complying with all applicable regulations and laws. Please see the FAQs below for more detail.
