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Zdrowie i gospodarka · 22/11/2021

Effective Date of Requirement for Premarket Approval for Blood Lancets

The Food and Drug Administration (FDA, Agency, or we) is issuing a final order to require the filing of a premarket approval application (PMA) or notice of completion of a product development protocol (PDP) following the reclassification of multiple use blood lancets for multiple patient use from class I to class III.

Source: Federal Register — Food and Drug AdministrationOpen original release →