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US FDA Plans Up-Classification of Blood Lancets

US regulators have proposed reclassifying three major types of medical devices used to obtain blood samples for diagnostic purposes from Class I to Class II or III.The agency’s proposed orders target...

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US FDA plant Neuklassifizierung von Lanzetten in risikoreicheren Klassen

Die US-Behörde hat vorgeschlagen, drei wichtige Medizinproduktearten zur Abnahme von Blutproben zu Diagnosezwecken von Klasse I auf Klasse II oder III höherzustufen.Der Vorschlag betrifft drei Arten...

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US FDA Medical Device Classification Primer

US FDA Medical Device Classification PrimerOverview of US FDA medical device classification requirementsRead more

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