FDA Watch: Agency to Use EUA Pathway to Clear New Coronavirus Detection Tests
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FDA Watch: Agency Exempts Dozens of Tests from 510(k) Review
On Dec. 30, 2019, the U.S. Food and Drug Administration (FDA) published a final order exempting dozens of Class I and Class II medical devices that previously required 510(k) submission from 510(k) premarket review
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FDA Watch: Agency Targets Sale of IVD Reagents without Premarket Approval
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FDA Watch: Agency Targets Sale of IVD Reagents without Premarket Approval
Distribution of diagnostics and devices without premarket approval has featured prominently on the FDA’s enforcement priority list this year. The agency has issued seven warning letters related to premarket approval in 2019 after issuing just one such warning letter in all of 2018.
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FDA Watch: Agency Clears the Way for Approval of Blood-Based PSA Test
The U.S. Preventive Services Task Force (USPTF) recommends that men age 55 to 65 consider prostate cancer screening. The reason it doesn’t directly recommend testing for all men in this age group is that current screening methods that rely on detecting high levels of
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