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GUIDANCE DOCUMENT

Safety Considerations to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications Guidance for Industry and Food and Drug Administration Staff February 2015

Download the Final Guidance Document
Final
Docket Number:
FDA-2012-D-0630
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This guidance provides recommendations to manufacturers, FDA reviewers, and other entities involved in manufacturing devices that contain small-bore connectors designed for enteral feeding, as well as those submitting or reviewing premarket notification submissions [510(k)s] for these devices. Small-bore connectors provide a mechanism for the connection between a variety of medical devices including those with enteral and non-enteral (e.g., intravenous) 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.

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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2012-D-0630.

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