Esta tradução está a ser preparada. Entretanto, mostramos temporariamente a versão original em inglês.
Negócios · 20/01/20101 min de leitura
Draft Guidance for Industry and Food and Drug Administration Staff; Heart Valves - Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications; Availability
Tradução automática local · Idioma original da fonte
Resumo
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled "Heart Valves -- Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications." This draft guidance document describes FDA's recommendations about investigational device exemption and premarket approval applications for heart valves. This draft guidance document is not final, nor is it in effect at this time.
Idioma original da fonte: Federal Register — Health and Human ServicesAbrir o comunicado original →