PMA with FDA
FDA Conclusion
In March 2020, Auralsplint Inc. PBC voluntarily submitted the Auralsplint treatment for Pre-Market Approval with the FDA. 9 weeks later, after several discussions, a conclusion was made declaring the Auralsplint a Class 1 Medical Device by definition requiring prescription by licensed veterinarians, as part of a whole treatment in clinic including routine exam and any other needed pathology to determine the 'cause' for the hematoma. It is Auralsplint's understanding the 'cause' of the hematoma is the ear has a broken blood vessel due to the actions by animal to shake the ears for relief from a condition. The condition is important to diagnosis and treat to keep from return behavior. In no way is the Auralsplint replacing a licensed veterinarian. However, with the Auralsplint in location, and the ear canal open and exposed, any underlying condition is treatable after installation. We would recommend the Auralsplint as a first line of defense for the aural hematoma affliction and the underlying conditions treatable at time of veterinary visit. If unable to have vet treat the affliction, then the layperson is left to treat themselves. The Auralsplint treatment kit is suitable for both clinical application, and by the animal owner at home. Below is the exact FDA statements.
Accordingly, we conclude that Auralsplint is not safe except under the supervision of a licensed veterinarian and adequate directions for layperson use cannot be written for it. Auralsplint is therefore a prescription animal device under 21 CFR 801.109 and must be dispensed only upon the written order of a licensed veterinarian or used under the supervision of a licensed veterinarian. Please note that because appropriate treatment of aural hematomas in dogs, including proper diagnosis, treatment, and management of underlying conditions and potential complications, requires the training and expertise of a licensed veterinarian, changing the current labeling to incorporate additional instructions, warnings, or disclaimers, would not change the conclusion that it is a prescription animal device.
Prescription animal devices are exempt from section 502(f)(1) of the FD&C in that they do not require adequate directions for use for a lay person if they comply with all of the requirements in 21 CFR 801.109. Among other things, 21 CFR 801.109 requires that prescription animal devices be dispensed only upon the written order of a licensed veterinarian or used under the supervision of a licensed veterinarian. In addition, they must carry the veterinary prescription legend: “Caution: Federal law restricts this device to sale by or on the order of a licensed veterinarian.” Their labeling must also follow the other labeling requirements in 21 CFR 801.109, including bearing “information for use, including indications, effects, routes, methods, and frequency and duration of administration, and any relevant hazards, contraindications, side effects, and precautions under which practitioners licensed by law to administer the device can use the device safely and for the purpose for which it is intended…”. 21 CFR 801.109(c).
