Devices Pretending to be Medical Devices on Amazon, and FDA is Helpless.
(Thursday, April 25, 2024) The FDA made a public announcement this week asking consumers to not use anti-chocking devices, saying that they are not effective and that manual anti-choking procedures are much better. Anti-choking devices are popular, particularly with parents trying to be prepared for accidental choking of their children. However, the lack of FDA enforcement highlights the limits of the current regulations, and this is true for many products. For a device to be regulated as a medical device, it must be intended to treat or prevent a disease. Regulated devices need to, at a minimum, register with the FDA (which entails a yearly registration fee), and may require performance evaluation (which includes bench or lab testing and may require clinical trials) followed by formal clearance or approval by the FDA, all of which adds significant expense to develop such devices. However, if a device can be designed such that it does not make a specific claim to treat or prevent a disease, while still doing pseudo-medical procedures, it will not fall in the category of an FDA-regulated medical device, and hence will not need to go through the FDA, while still being sold in the market. Anti-Choking devices fall into this category. Choking is an accidental event that is not considered a disease although it could lead to death if not managed within minutes of the event. Although rescue protocols include abdominal thrusts (called the “Heimlich” maneuver) have been known for decades and promoted by the Red Cross as the preferred way to treat choking, many devices marketed as Anti-Choking devices are available commercially basically providing an alternative to the Red Cross-recommended procedure. There are 70+ anti-choking devices available on Amazon. None of these devices have been approved by the FDA because they skirt the strict definition of a medical device that would require FDA approval, and instead make watered-down claims to do the same without claiming it. And there isn’t much the FDA can do. There are very few warning letters to manufacturers of these devices only if the manufacturer pushes the envelope too far. The FDA announcement highlights the gray area of enforcement where despite concerns about the utility or even safety of the products, the FDA is unable to order these products off the market. As the FDA stated in its announcement, these devices could delay the procedure and potentially hurt the patient. It is left to the consumers to self-educate themselves about the best way to manage this potentially life-threatening event. AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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