Course: ME 506. Regulatory Affairs of Medical Devices (3)
The United States Food and Drug Administration is responsible for the safety and efficacy of medical devices sold in the United States. This course will focus on Title 21 Subchapter H (Medical Devices) of the Code of Federal Regulations, in particular Part 820 (Quality System Regulation) which governs the design, development, manufacture and post-sale facets. Other parts relevant to Medical Device Design and Development such as Part 801 (Labeling) and Part 822 (Post Market Surveillance) will also be discussed.