This is study material that is intended only 
     to give students an overview of the procedures 
     FDA has used in clearing new medical devices 
     for marketing.  It is not to be used as a 
     resource by persons who are involved in the 
     medical device industry because it is a summary 
     that omits much critical information and the 
     regulations are changing constantly.  Persons 
     intending to market medical devices must consult 
     the primary source documents such as the 
     FEDERAL REGISTER and the Code of Federal 
     Regulations to obtain accurate and up-to-date 
     information on this subject.

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• Figure 1. Basic Substantial Equivalence Determination
• Figure 2. SE Detailed Pathway
• Figure 3. The New 510k) Paradigm
• Appendix I. Format for 510(k)s
• Appendix II. PMA Filing Review
• Appendix III. Statistical Checklist