If you have any questions you'd like to ask the Horseracing Integrity and Safety Act (HISA) Authority or the Horseracing Integrity and Welfare Unit (HIWU), please feel free to send them over to us at the following email address: danross@thetdn.com.Q: Trainer Librado Barocio was recently suspended 45-days after he was found in possession of several syringes, hyperemic needles and vials of Polyglycan, a joint injection that's officially deemed a medical device. Can you explain what the difference is between a “medical device” and an FDA-approved drug? When it comes to intra-articular joint injections specifically, does HISA regulate medical devices and FDA-approved drugs differently? If not, why not?A: From a HISA spokesperson.According to the Federal Food, Drug, and Cosmetics Act, a medical device is “an instrument, apparatus, implant, or similar article used to diagnose, treat or prevent disease, or to affect the body's structure or function, without achieving its primary purpose through chemical action or metabolism.” This includes, among other items, hypodermic needles and syringes. Polyglycan is also regulated by the U.S. Food and Drug Administration (FDA) as a medical device and acts by mimicking the physical properties of equine synovial fluid.Generally speaking, the primary difference between a medical device and a drug is how they work: drugs work through chemical reactions and are metabolized (processed) by the body, while medical devices work through physical, mechanical or technological methods without relying on chemical action or metabolism.HISA's racetrack safety rules prohibit the possession of injectables of any kind on racetrack grounds. For purposes of regulating intra-articular injections specifically, HISA imposes a stand-down time on high-speed exercise following any substance administered intra-articularly.Additional information about HISA's regulation of joint injections, which fall under the Racetrack Safety Program, can be found here. Extra-label use of Polyglycan (e.g., intravenous or intramuscular administration) is not permitted by the FDA and, as a result, not permitted under HISA rules. The only recognized use is intra-articular administration.The post Ask HISA: Medical Devices And FDA Approval appeared first on TDN | Thoroughbred Daily News | Horse Racing News, Results and Video | Thoroughbred Breeding and Auctions.