Discussion Question 4.2

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The University of Tennessee, Knoxville *

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3505

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Mechanical Engineering

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Jan 9, 2024

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docx

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Discussion Question 4.2 Questions: In its 2011 report, the Institute of Medicine concluded that the 510(k) clearance system “lacks the legal basis to be a reliable premarket screen of the safety and effectiveness of moderate risk devices and, furthermore, that it cannot be transformed into one.” Do you agree? In your view, what are the advantages and drawbacks of the existing 510(k) clearance system? Should the FDA eliminate the 510(k) system are require premarket approval of all new medical devices, as it currently does for all new drugs? - The advantages of the current 510(k) clearance system are: quicker approval process, allows changes to existing devices, easier to bring existing devices up to standard, and reduced costs. - The disadvantages of the current 510(k) clearance system are: substantially equivalent devices may be subject to unnecessary safety and efficacy testing again, it is susceptible to fraud and abuse, allows manufacturers to bypass necessary premarket testing and clinical trials. - I do not believe the FDA should eliminate the 510(k) clearance system because it has more advantages than disadvantages. The clearance provides a more cost effective option for manufacturers to market their products. Without the clearance, there may be a backlog of approvals because of the standard review period. The FDA could revamp the system to focus more on safety and efficacy measures that pose the greatest risk for patients. The number one goal of all regulations is public safety.
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