HW1 Study Guide

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Mechanical Engineering

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Apr 3, 2024

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BME 153 Fall 2023 HW1 Study Guide HW1 Study Guide 1. How are medical devices classified by the FDA in the US? 2. Provide examples of Class I medical devices. 3. Provide examples of Class II medical devices. 4. Provide examples of Class III medical devices. 5. What is the regulatory pathway for Class II medical devices? 6. What is 510(k)? 7. What is PMA? 8. Name the regulatory pathway for each of the medical device: a. A new continuous blood glucose monitor b. A new vein endoprosthesis that has a minor design change from its FDA-approved predicate product. c. A breast implant with a new type of anti-adhesion coating 9. Which device in question 8 will most likely require a clinical trial? 10.Explain why randomized trials are usually not required for medical device clinical trials. 11.What are the main study design differences between a device clinical trial and a drug clinical trial? 12.An estimate of _______ % of total hip replacements fail after 15 years. 13.Describe the main differences between a hip replacement and hip resurfacing. 14.What was the main cause that metal-on-metal hip replacement had a higher failure rate and plastic-on-metal hip replacement, despite having the same metallic material?
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