chapter  15
38 Pages

- Regulatory Affairs: Medical Devices

Introduction ............................................................................................................296 Regulatory Requirements Are Enforced by Law ..............................................296 Make Regulatory Affairs Cost-Effective ...........................................................296 Regulatory Requirements Improve Device Safety and Effectiveness ...............297 Regulatory Affairs Requires Good Judgment ...................................................297

FDA Overview and Authority ................................................................................ 298 Important FDA Jurisdiction Acts, History, and Assistance ............................... 298 Online Assistance ..............................................................................................299

Basics: Short Discussion of Establishment Registration, Device Submissions, Device Listing, and Device Classication .......................................299