Medical Device; exemption from premarket notification; class II devices; pharmacy compounding systems. Final rule.
The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from the premarket notification requirements for pharmacy compounding systems classified within the intravascular administration set, with certain limitations. This rule will exempt from pre market notification pharmacy compounding systems classified within the intravascular administration set and establishes a guidance document as a special control for this device. FDA is publishing this order in accordance with the Food and Drug Administration Modernization Act of 1997 (FDAMA).
D018795:Device Approval / Q000331:legislation & jurisprudence*; D004339:Drug Compounding / Q000145:classification* / Q000295:instrumentation; D004867:Equipment Design; D004869:Equipment Safety; D006801:Humans; D007880:Legislation, Drug; D014481:United States; D014486:United States Food and Drug Administration