title: Gastroenterology-urology devices; reclassification of implanted blood access devices. Final rule.
abstract: The Food and Drug Administration (FDA) is issuing a final order to reclassify implanted blood access devices, a preamendments class III device, into class II (special controls) based on new information and subject to premarket notification and to further clarify the identification.
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence*; D004869:Equipment Safety / Q000145:classification*; D005762:Gastroenterology / Q000295:instrumentation; D006801:Humans; D014481:United States; D014572:Urology / Q000295:instrumentation; D062666:Vascular Access Devices / Q000009:adverse effects / Q000145:classification*