최신자료
The 510(k) Third Party Review Program: Promise and Potential
In a follow-up to their prior working paper, Brian Miller, William Blanks, and Brian Yagi published a review of 510(k) Third Party Review Program in the Journal of Medical Systems. In their article, they review how the medical device industry innovates rapidly, improving existing devices and creating new ones: between 1976 and 2020, FDA’s Center for Devices and Radiological Health (CDRH) approved or cleared approximately 155,000 new devices for human use. Approximately 99% of clearances utilized the 510(k) pathway, an application and review pathway reserved for low- and moderate-risk devices that have incremental changes to a previously approved “predicate” device. As such, 510(k) applications have distinct evidentiary requirements and must demonstrate substantial equivalence to a predicate device to gain clearance.
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