Legend device definition
Legend device means a device which, because of any potential for harmful effect or the method of its use, is not safe except under the supervision of a practitioner;
Legend device means a device, which because of any potential for harmful effect or the method of its use, is not safe -- except under the supervision of a practitioner. These devices, as approved by the Food and Drug Administration, may be labeled "Caution: Federal (USA) law restricts this device to sale by or on the order of a physician."
Legend device means a device that is required by applicable federal or state law to be dispensed pursuant only to a prescription or is restricted to use by prescribing practitioners only or that, under federal law, is required to bear either of the following legends: (A) "RX ONLY" IN ACCORDANCE WITH GUIDELINES ESTABLISHED IN THE FEDERAL FOOD, DRUG AND COSMETIC ACT; or (B) "CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE FOR USE BY OR ON THE ORDER OF A LICENSED VETERINARIAN.";
More Definitions of Legend device
Legend device means an instrument, apparatus, implement, machine, contrivance, implant, or other similar or related article, including any component part or accessory, which is required under federal law to bear the label, “Caution: federal or state law requires dispensing by or on the order of a physician” and/or “Rx Only”, or any other designation required under federal law.
Legend device means any device intended for use by humans that carries on its
Legend device means the definition contained in section 20-571 of the Connecticut General Statutes.
Legend device means a device that is required by applicable
Legend device means “legend device” as defined in section 20-571 of the Connecticut General Statutes;
Legend device means any device intended for use by humans that
Legend device means a device that bears the statement "Caution: U.S. Federal law restricts the _________________ to sale by or on the order of a physician."