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Told.pdf

HMTG-114-IF14-Wstate-ShurenJ-20151117.pdf

🔗 Source: docs.house.gov

📊 Size: 80 KB

📄 Pages: 12 pages

⬇️ Downloads: 52

Summary

Dr. Jeff Shuren, Director of the Center for Devices and Radiological Health at the FDA, testified before the Subcommittee on Health, discussing the importance of diagnostic tests in medicine and the FDA's role in ensuring their safety and effectiveness. The FDA regulates in vitro diagnostic devices (IVDs) under a risk-based framework, assigning them to one of three classes: Class I (low risk), Class II (moderate risk), and Class III (high risk). The primary risk posed by IVDs is the risk of undetected inaccurate test results, which can lead to harm, injury, or death. The FDA applies premarket review and post-market controls to ensure the safety and effectiveness of IVDs, with the level of regulation depending on the level of risk posed by the test.

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File Format: PDF
File Size: 80 KB
Pages: 12
Language: EN
Total Downloads: 52
Last Updated: 7 days ago

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This PDF document about told provides comprehensive information and guidance. Whether you're a beginner or advanced user, this resource offers valuable insights into told.