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FDA lowers nucleic-acid-based TB test risk classification

from Medscape Medical News

The risk classification for nucleic acid–based tests is being downgraded from class 3 (high risk) to class 2 (moderate risk) by the U.S. Food and Drug Administration (FDA), which will allow for easier approval of such tests. Class 3 device classification requires a more rigorous premarketing application and approval process. "This rule would lower the current risk classification for nucleic acid-based tests allowing manufacturers to utilize the faster, more streamlined clearance pathway for medical devices," according to the FDA. more


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