Why do all these companies get to sell a Nebulizer, a prescription only device, direct to consumers?
I asked this question several years ago and have recently contacted the FDA in regards to 513g to understand more about what nebulizers are OTC. Their response was that all nebulizers, whether portable or handheld, desktop or compressor, are class II, need a 510k and are prescription only. So why do all of these companies:
https://www.amazon.com/gp/bestsellers/industrial/8297518011/ref=pd_zg_hrsr_industrial
Get to sell prescription devices on amazon.com? There literally is no such thing as an OTC nebulizer 510k.
So how is this legal? @Steve_Amazon I saw your name in a post about nebulizers and you mentioned the professional healthcare program. Why do all of these companies get to sell prescription nebulizers without requiring a prescription?
Why do all these companies get to sell a Nebulizer, a prescription only device, direct to consumers?
I asked this question several years ago and have recently contacted the FDA in regards to 513g to understand more about what nebulizers are OTC. Their response was that all nebulizers, whether portable or handheld, desktop or compressor, are class II, need a 510k and are prescription only. So why do all of these companies:
https://www.amazon.com/gp/bestsellers/industrial/8297518011/ref=pd_zg_hrsr_industrial
Get to sell prescription devices on amazon.com? There literally is no such thing as an OTC nebulizer 510k.
So how is this legal? @Steve_Amazon I saw your name in a post about nebulizers and you mentioned the professional healthcare program. Why do all of these companies get to sell prescription nebulizers without requiring a prescription?
5 replies
Seller_hJFRBH2k1PMSc
@Steve_Amazon following up and adding moderators who have answered restricted medical device questions in the past:
@Glenn_Amazon@Blake_Amazon@Danny_Amazon@Troy_Amazon@Emet_Amazon
As mentioned in the original post, why do all of these sellers get to sell nebulizers, which are prescription only class II medical devices, directly to amazon customers?
https://www.amazon.com/gp/bestsellers/industrial/8297518011/ref=pd_zg_hrsr_industrial
How is this legal? I've contacted the FDA through 513g to verify that there is no such thing as an OTC 510k for a nebulizer. These listings are not being sold through the Amazon healthcare program. None of these companies are even registered with the FDA. And some of these listings are 5 years old.
So back to my original question:
Why do all of these companies get to sell prescription nebulizers without requiring a prescription?
Danny_Amazon
Hello @Seller_hJFRBH2k1PMSc- and thank you for turning to the forums on this topic. It is true that this classification of item is limited to sellers enrolled in the Professional Healthcare Program.
I appreciate you ensuring this situation was surfaced however, so I could escalate the issue for review by the appropriate stakeholder teams. While I will not be able to share any updates as that team completes their review, I do appreciate you looking to the forums to surface this.
Best,
Danny
