Bollinger_Austin_HW4_Biodevices_BME482.docx - Designs of...

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Designs of Biodevices BME 482 Homework 4: FDA Regulatory and Reimbursement Pathways Austin Bollinger [Q849E539] Instructor: Dr. Yongkuk Lee Due Date: October 28, 2018
FDA Regulatory Pathways Electrocardiograph Cardiovascular – Cardiovascular Devices (OHT2) o Class II o Product Code – DPS
Engineering Designs – Class II – (510)k Timeline: (60 months) Design (12 months) o Average period to be able to create a design for a product that benefits overall health and biocompatible to the human body and finding the best solution through the design process that meets critical needs by fitting the overall solution. Prototyping and Testing (18 months) o Period to test multiple products that came out of the design process and be able to narrow down to one product that is efficient and accurate to the design needs and criteria. FDA Class II Approval (6 months) This process can take up to 6 months to complete after submission and can be done after prototyping and testing.

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