Position on Animal Medical Devices in Equine Practice

Preamble

Animal medical devices are widely used in equine practice for diagnosis and treatment. However, distinctions between animal medical devices and animal drugs are not always clear. Importantly, animal medical devices are not limited to physical equipment; some products, including injectable products, may be marketed as devices depending on their intended mechanism of action. Confusion regarding regulatory status may place horses, veterinarians, and horse owners at risk and create uncertainty in clinical decision-making.

FDA regulation of animal medical devices is significantly less stringent than for human medical devices. Animal medical devices (including those marketed for equine) are not subject to FDA review for safety and effectiveness prior to coming to market, placing the responsibility for ensuring safety, effectiveness, and proper labeling solely on manufacturers and distributors, without independent pre-market oversight.

AAEP’s Position

The AAEP recognizes the need for the responsible use of devices in equine practice. The AAEP believes it is paramount that veterinarians receive ongoing education on FDA regulatory frameworks for animal drugs and devices, as well as continued dialogue with regulatory agencies to promote appropriate oversight of devices without unduly limiting innovation or access to beneficial technologies.

The AAEP recognizes the distinction under the Federal Food, Drug, and Cosmetic Act between:

• Medical devices, which achieve their primary intended purpose without chemical action or metabolism; and
• Animal drugs, which act through chemical action or metabolism and are subject to FDA approval, conditional approval, or indexing requirements.

Products that meet the definition of an animal drug should not be marketed as devices to circumvent FDA drug approval requirements.

Veterinarians are obligated by the Animal Medicinal Drug Use Clarification Act (AMDUCA) to prescribe and use FDA-approved, conditionally approved, or indexed animal drugs when such products are available and clinically appropriate. The AAEP discourages the use of unapproved animal drugs marketed as devices. Furthermore, the AAEP recognizes the guidelines provided in AMDUCA regarding the extra-label use of approved drugs and reminds practitioners that these guidelines do not apply to devices.

Because devices intended for animal use are not subject to FDA pre-market approval and do not undergo ongoing regulatory oversight of manufacturing processes once marketed, veterinarians should:

• Exercise professional judgment when selecting and using animal medical devices;
• Critically evaluate available scientific evidence supporting safety and effectiveness;
• Only use devices in a manner consistent with their intended instructions for use;
• Not misrepresent animal medical devices to clients as generic drugs, which are different; and,
• Communicate to clients whether a product is an animal medical device or an FDA-approved drug; discuss relevant risks, benefits, and alternatives; and document such interactions in the medical record.

Be Advised

Should a practitioner choose to use an animal medical device as a pharmaceutical or in a manner inconsistent with the instructions for use, they should be aware that these products have not been evaluated by any regulatory agency for suitability for that use, and this should be communicated to the client. The final decision on whether to use these products should be based on what is in the best interests of the equine patient.

Increased liability risk may apply when an animal medical device is used in a manner inconsistent with the label. Veterinarians should confirm coverage with their liability insurance provider before using unapproved products.

Animal medical device manufacturers are not required to report adverse events to the FDA. Therefore, the AAEP and FDA encourage veterinarians to report adverse drug experiences and product defects associated with drugs and devices to the FDA. Instructions on how to report adverse events for unapproved drugs and medical devices can be found here.

Resources

Further information concerning definitions and regulations is available through the following resources:

• How can I tell if a drug is legally marketed for animals?
• How FDA regulates animal devices?
• How to report animal drug and device side effects and product problems
• Animal Drugs Marketed as Animal Devices

Contact the FDA Center for Veterinary Medicine at AskCVM@fda.hhs.gov or 1-888-332-8387.

Approved by AAEP board of directors in 2006.