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| BME 56200 - Regulatory Issues Surrounding Approval Of Biomedical Devices |
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Associated Term:
Fall 2021
Learning Outcomes: 1. Use the appropriate regulatory classification and pathway for any medical device in the U.S. 2. Describe the significance of each major component of a 510(k) submission. 3. Describe the significance of each major component of a PMA submission. 4. Develop awareness for the need to seek country-specific expertise to prepare submissions for countries outside the U.S. 5. Select the appropriate messages and clearly present, in both oral and written communication, in a mock FDA meeting. 6. Identify contents of a CER and know the strategy for writing a CER. Required Materials: Technical Requirements: |
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