Food and Drug Administration Approval Process for Medical Devices

Catalog description

This course provides an overview of FDA and select international regulations associated with medical devices, and those requirements to be followed when submitting one for approval or clearance. Examples of topic areas include: The Structure of the FDA and global approval agencies, Framework of regulatory approvals, Classification of medical devices for approval, Relevant US and international test methodologies, Guidance for conducting clinical trials, Good manufacturing practices and quality systems to be adopted, and Surveillance of medical devices. Individuals engaged in the development of medical devices and diagnostic tools, as well as those in healthcare studies wishing to learn more about their evaluation and approval, would benefit from information discussed in this course. Prerequisites: ENGR 100, CHEM 121, BIOL 111