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Purpose of the document The purpose of the document is to introduce a foundational approach, harmonized vocabulary and general and specific considerations, for manufacturers, regulators, and users alike to address the unique challenges associated with the use of SaMD by; 

 • Establishing common vocabulary and an approach for categorizing SaMD;

 • Identifying specific information for describing SaMD in terms of the significance of the information provided by the SaMD to the healthcare decision, healthcare situation or condition, and core functionality;

 • Providing criteria to categorize SaMD based on the combination of the significance of the information provided by the SaMD to the healthcare decision and the healthcare situation or condition associated with SaMD; and

 • Identifying appropriate considerations, during the lifecycle process (requirements, design, development, testing, maintenance and use) of SaMD.