Draft Guidance for Industry and Food and Drug Administration Staff; Safety Considerations for 510(k) Submissions To Mitigate the Risks of Misconnections With Small-Bore Connectors Intended for Enteral Applications; Availability

Samenvatting

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Safety Considerations for 510(k) Submissions to Mitigate the Risks of Misconnections with Small- bore Connectors Intended for Enteral Applications." The use of common connector designs, such as luer connectors, has led to unintended connections between devices that have different intended uses and has resulted in serious and sometimes fatal consequences to patients. This guidance provides recommendations to 510(k) submitters regarding the submission expectations regarding design and testing to reduce the risk of unintended connections between enteral and nonenteral devices. This draft guidance is not final nor is it in effect at this time.