Animal medical devices A medical device, as defined in the act, is:
The term “drug” means articles recognized in the official U.S. Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary; articles intended to diagnose, mitigate, treat, cure, or prevent disease; and non-food items intended to affect the structure or function of the body. A new animal drug is defined (in part) as “ any drug intended for use for animals other than man, the composition of which is not generally recognized among experts qualified by scientific training and experience as safe and effective for use under the conditions prescribed, recommended or suggested in its labeling. ” There are, for all practical purposes, no animal drugs that are not also new animal drugs. The Green Book, accessible from the CVM home page, contains a searchable database of all FDA-approved animal drugs. 5 Unapproved new animal drugs may be distributed if the drug will be used for research, that is, for the collection of data intended to be submitted in support of approval. Investigational New Animal Drug (INAD) regulations provide that such drugs may be distributed for use only by experts, qualified by scientific training and expertise, to investigate the safety and effectiveness of animal drugs. Before a new animal drug receives FDA approval, the sponsor must establish that the new animal drug is safe and effective: ● Safe includes safety to the animal, safety of food products derived from the animal, safety to persons administering the drug or otherwise associated with the animal, and safety in terms of the drug’s environmental impacts. ● Effective means that the product will consistently and uniformly do what the labeling claims it will do. Drug sponsors submit a new animal drug application (NADA) along with supporting data, including all adverse effects associated with the drug’s use. The FDA performs a detailed and comprehensive review, determining whether data were developed in accordance best practices and evaluating the data for safety and efficacy. For drugs used in food animals, the drug producer must also demonstrate that drug residues are safe for human consumption and provide acceptable analytical methods capable of detecting the drug and its metabolites in animal tissue. be properly administered, and the course of the disease can be followed to assess treatment success. Prescription products must bear the legend: “ Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.” The same drug substances can be marketed in different forms, intended for use by different routes of administration and in different species of animals. Thus, these drug products may be labeled prescription in some cases and over-the counter (OTC) in others. The veterinarian has sufficient knowledge of the animal(s) to initiate at least a general or preliminary diagnosis of the medical condition of the animal(s). This means that the veterinarian has recently seen and is personally acquainted with the keeping and care of the animal(s) by virtue of an examination of the animal(s) or by medically appropriate and timely visits to the premises where the animal(s) are kept. The veterinarian is readily available for follow-up evaluation, or has arranged for emergency coverage, in the event of adverse reactions or failure of the treatment regimen. 6 Veterinarians employed by drug manufacturers or distributors may not legally dispense prescripti on drug products to laypersons unless they meet the foregoing criteria. Similarly, practicing veterinarians or their employees may not legally sell animal prescription drug products to walk-in customers outside the context of a valid VCPR.
An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component part, or accessory, which is … intended for use in the diagnosis of disease, or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals and which does not achieve any of its principal intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its principal intended purposes. Articles such as screening test kits for drug residues are regulated as animal medical devices. Animal medical devices do not require premarket FDA approval, but they are subject to provisions of the act related to misbranding and adulteration. For example, an animal medical device is misbranded if the labeling is false or misleading, if it does not have adequate directions for use by a layperson, or if it is dangerous to animal or human health when used as directed. The FDA relies on veterinarians and other users to report unsafe animal medical devices. If adequate directions cannot be written for lay use, the animal medical device is deemed unsafe for use except under the supervision of a licensed veterinarian. Therefore, its label must bear the statement: “Caution: Federal law restricts this device to sale by or on the order of a licensed veterinarian.” Examples of animal medical devices required to bear the prescription legend include transcutaneous electronic nerve stimulators, pulse magnetic field devices, and lasers. Animal grooming aids The act defines a cosmetic as pertaining only to human use, so products intended for cleansing or promoting attractiveness in animals are not subject to FDA control. However, if such products are intended for a therapeutic purpose, they are subject to regulation as new animal drugs. Drug approval process Classifying prescription and over-the-counter animal drugs The FDA determines the marketing status (prescription, over- the-counter, or VFD) of animal drugs based on whether it is possible to prepare “adequate directions for use” that would allow a layperson to use the drugs safely and effectively. Safe use includes safety to the animal, safety of food products derived from the animal, safety to the persons associated with the animal, and safety in terms of the drug’s impact on the environment. Effective use assumes that an accurate diagnosis can be made with a reasonable degree of certainty, the drug can Dispensing veterinary prescription drugs Because adequate directions for safe and effective lay use cannot be written for animal prescription drug products, such products can only be sold on the prescription or other order of a licensed veterinarian. Selling an animal prescription drug product to a layperson without a prescription is misbranding, subjecting the seller to civil and/or criminal penalties. A licensed veterinarian may legally use or dispense an animal prescription drug product only within the context of a valid veterinarian–client–patient relationship (VCPR). A valid VCPR is defined by the American Veterinary Medical Association as follows: A VCPR exists when all of the following conditions have been met: The veterinarian has assumed the responsibility for making clinical judgments regarding the health of the animal(s) and the need for medical treatment, and the client has agreed to follow the veterinarian’s instructions.
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