Medical devices; exemptions from premarket notification; class II devices; vascular tunnelers. Food and Drug Administration, HHS. Final rule.
The Food and Drug Administration (FDA) is publishing an order granting in part a petition requesting exemption from the premarket notification requirements for vascular tunnelers with certain limitations. This rule will exempt from premarket notification stainless steel vascular tunnelers of single unit construction. FDA is publishing this order in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA).
D018795:Device Approval / Q000331:legislation & jurisprudence*; D004869:Equipment Safety; D004864:Equipment and Supplies / Q000145:classification*; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration; D014656:Vascular Surgical Procedures / Q000295:instrumentation*