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    Citing Safety Risks, FDA Adopts New Standards for Small-Bore Connectors

    Even small devices can cause big problems. That's the conclusion of a new guidance document issued this week by the US Food and Drug Administration (FDA), which is trying to make "small-bore connectors" safer. Background The devices—technically a medical device—are used to temporarily connect two otherwise incompatible medical devices, FDA explains in its final guidance document, Safety Considerations to Mitigate the Risks of Misconnections with Smallbore Connectors I...
  • FDA Releases Draft Guidance on 510(k) Submissions

    The US Food and Drug Administration (FDA) has released a new draft guidance for its staff members and industry instructing them on how to assess the safety risks of small-bore connectors submitted through a 510(k) application. The 26 July document, Draft Guidance for Industry and Food and Drug Administration Staff - Safety Considerations for 510(k) Submissions to Mitigate the Risks of Misconnections with Small-bore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 , specif...