Draft Guidance for Industry and Food and Drug Administration Staff; Total Product Life Cycle: Infusion Pump-Premarket Notification [510(k)] Submissions; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled "Total Product Life Cycle: Infusion Pump--Premarket Notification [510(k)] Submissions." The recommendations in this guidance are intended to improve the safety and effectiveness of these devices. This draft guidance is not final nor is it in effect at this time. Elsewhere in this issue of the Federal Register, FDA is announcing a public meeting regarding external infusion pumps.