Premarket approval is the FDA process to evaluate a Class III device. This classification has the most stringent review and is reserved for those devices, blood devices or biologics that support or sustain human life, or may have substantial impact on human health, or present a potential for risk or illness. Class III devices are reviewed with exacting scrutiny by the FDA.
Smith Associates has the experience to guide your company through this process. As consultant for MedMira of Canada, MedMira has received their PMA for a Rapid HIV Test Kit.
Smith Associates can assist you in determining what PMA approach best suits your product:
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