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I need to know if the following product requires FDA...i

Customer Question

Hi. I need to know if the following product requires FDA...i talked with FDA...from what i gather this is not a medical device thus it is not regulated nor requires FBA. But i need to make sure 100% and have a code or link or something that shows it is
exepmt. Product: Known by various names: Chinese cupping, Massage Cupping, Traditional cupping, Nipple, clit, clitorious excitment, etc... its use depends on whose selling it online and how they describe it as.
Submitted: 2 years ago.
Category: Legal
Expert:  DrDLove replied 2 years ago.
Hello from JustAnswer.
You do not say what is the use, but it is the use that defines whether it is a medical device. If the use is to prevent, diagnose, or treat a medical condition, then it would be considered a medical device.
It is also not necessarily a static determination. Something that was originally developed for uses unrelated to the prevention, diagnosis, or treatment of medical conditions may be later found to be helpful for a medical condition, and once the device is used for the later purpose, it will then be considered a medical device, even if it was formally decided to not be a medical device when first developed. So, even if you could find a link to a prior determination, that would not necessarily still be true.
It is also the overall use of the device that is used in the determination. If many sellers claim a medical use, a single seller cannot claim that it is not a medical device by not claiming a medical use.
So, the only way that you can rely on whether the FDA would consider this a medical device would be to directly query the FDA. If the FDA has already informed you that it is not a medical device, then you would need to ask for a formal documentation of that determination, and that is the only document upon which you can rely.
If I can provide any clarification, please let me know.
Customer: replied 2 years ago.
Thank you Dr. for your response, but with all due respect im looking for someone who is an expert in FDA, not to argue if the product is or is not a medical device. If your google it, you see it is not a medical device, i havent seen any claims anywhere made that it heals or cures or helps with anything. And mostly in recent years it is sold as a "sex novelty" which i came across this website which states they have talked to FDA Press person and that sex (adult products) %98 are not regulated by FDA except some dildos perhaps. and if you google the product you see that many websites (ebay, amazon, private websites) label them as Adult Novelty (nipple stimulation, excitement)
Customer: replied 2 years ago.
And i dont need clarification, i have this product at customs, i need a clear link to FDA or some governmental website that clearly states whether this product is or is not FDA regulated and or some code as i initially mentioned. Thank you for your time
Expert:  DrDLove replied 2 years ago.
If they are used as a device to enhance sexual pleasure, then it would not be a medical device.
Customer: replied 2 years ago.
Thank you again Dr. Love but i need facts, codes, section, tariff, etc... you and i can talk about it all day. Have you had experience in importing products? i dont think you have Dr. i believe you have experience as physicians but not as importer or expert in products or FDA. If you want to learn more about this line of work contact FDA, they have a phone number and live person, According to FDA if it touches your body it requires FDA and products depend on their use. you say "If they are used as a device to enhance sexual pleasure, then it would not be a medical device" are you willing to bit on it? contact FDA and they tell you other wise, penis pumps, dildos, some other sexual equipment, all required FDA, according to FDA. Again, i need facts not opinions. They are sold everywhere online, but unless i have FACTS, codes, section, link to FDA or other governmental agency that proves they are exempt than FDA says FDA is required, as i was told by CBP (customs and border protect/customs clearance) the burden of proof is on me.