ABSTRACT
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
