In this section you will find the complete set of treatment instructions and links to articles about the Auralsplint Treatment. Veterinarians requesting Instructions for review, please email Daniel at Auralsplint@yahoo.com, or call at 817-228-6401 for faster service.
Study Manuscript: Auralsplint Descriptive Report - DOI: 10.13140/RG.2.2.13717.55520
Persuasive Essay: Pinna Surgery versus Pinna Splinting - https://www.linkedin.com/posts/daniel-whitton-08399a86_canine-aural-hematoma-surgery-versus-splinting-activity-6680527616102998016-eWHM
Article: Crinkled Ear Effect - https://www.linkedin.com/pulse/crinkled-ear-effect-daniel-whitton
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).
To receive a form letter for Requisition of no-cost Auralsplint Treatment Kits, email Daniel at Auralsplint@yahoo.com. All requisitions have to be made through the attending licensed veterinarian.
Auralsplint - Aural Hematoma Treatment Canine
Auralsplint Inc. PBC Justin, TX 76247 US
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