Three new general devices were classified as class II with special controls by the US Food and Drug Administration, all effective 16 August.
Device Classifications For COVID, Acute Febrile Illness IVDs And Force Separation Catheters
The FDA designated class II special controls classifications for two diagnostics and force separation catheters.
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AdvaMed’s top priorities for the 119th Congress include modernizing US Medicare services and expanding patients’ access to the latest medical technologies.
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The Visby Medical Women’s Sexual Health Test is the first over-the-counter test cleared by the US Food and Drug Administration to detect chlamydia, gonorrhea and trichomoniasis. It delivers results in about 30 minutes.