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.