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, ...
Since the passage of the Medical Device Amendments of 1976, the FDA’s the Center for Devices and Radiologic Health (CDRH) has been responsible for regulating medical devices. These devices have a ...
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