This all-new edition provides the most complete and current analysis of the U.S. medical device development and approval requirements available anywhere. Going beyond device law and regulation, this text presents practical, real-world, strategic analyses for expediting device product clearances and dealing with the CDRH. Also featured are detailed analyses of the most recent regulatory reforms implemented under the FDA Modernization Act, and discussions on how emerging developments and trends are reshaping medical device regulation in the United States.