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The current regulatory impact analysis on SE reports indicates that whatever data are submitted, it should include test protocols, quantitative acceptance criteria, and test results as well as clearly identify when national or international standards are used to test the new and predicate products in addition to explaining any deviations from the standard or stating if no testing standards were used

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Always seek the guidance of your physician or other qualified healthcare provider with any questions you may have regarding a medical condition or treatment. Results may vary : Treatment outcomes and health experiences may differ based on individual medical history, condition severity, and response to care. Emergency Notice : If you are experiencing a medical emergency, call 911 or seek immediate medical attention.