• Regulatory NewsRegulatory News

    New Report Compares FDA Quality System Requirements With ISO 13485:2016

    The Association for the Advancement of Medical Instrumentation (AAMI) this week released a technical information report to help the medical device industry prepare for the revision of 21 CFR 820 (also known as the quality system regulation), which will harmonize with ISO 13485:2016 later this year. The most recent regulatory agenda says that sometime this month the US Food and Drug Administration (FDA) will issue a proposed rulemaking on the harmonization and moderniz...
  • Regulatory NewsRegulatory News

    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...