Dear Amazon Legal Team,

I am writing on behalf of our client, a registered medical device manufacturer and distributor, to formally notify Amazon of the ongoing illegal sale of Class II medical devices on your platform, specifically Nebulizers and Saline for Inhalation - under FDA Product Code CAF.

We have identified numerous listings on Amazon.com for:

1. Prescription-only Nebulizer devices classified under FDA Product Code CAF (Jet and Ultrasonic Mesh)

2. Saline for Inhalation, which is regulated as a Class II prescription-only medical device when intended for inhalation delivery (also under product code CAF).

These illegal listings can be found here:

https://www.amazon.com/gp/bestsellers/industrial/8297518011/ref=pd_zg_hrsr_industrial

Per 21 CFR § 868.5630 and the associated product classification, these devices require:

• An active FDA registration and device listing

• Premarket notification [510(k)] clearance

• Sale and distribution under prescription-use only conditions, as indicated by 21 CFR 801.109

As per FDA guidance document, “Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators”

• Nebulizers are a prescription-only medical device

Many of the products currently sold via Amazon Marketplace by third-party sellers:

• Are not registered with the FDA as manufacturers or distributors

• Lack 510(k) clearance for the specific intended use

• Fail to display the required prescription labeling, and

• Are being sold directly to consumers without a prescription, in direct violation of FDA and Amazon Medical Device Policies

As per June 9th, 2025, 128 listings of prescription-only Nebulizers and 21 listings of prescription-only Saline for Inhalation are being sold on Amazon.com.

This presents a significant regulatory violation and a potential public health risk, as consumers are unknowingly purchasing and misusing prescription devices without clinical oversight.

Requested Actions:

We respectfully request that Amazon:

1. Immediately remove all listings of nebulizers and saline for inhalation products marketed under FDA Product Code CAF without verified prescription-use controls;

2. Require all sellers of CAF-classified devices to submit valid FDA establishment registration numbers and 510(k) documentation;

3. Re-implement a manual yank for the Nebulizer category to ensure prescription-only medical devices are not offered to the general public.

We have already provided a list of specific ASINs to the FDA’s allegation of abuse team and abuse-escalation @ amazon.com. This same posting will be sent to Amazon legal. This posting is for record on a public forum as Amazon has been aware of this issue since the FDA first notified them to take action against this dangerous and illegal activity in April 2024.

Please confirm receipt of this notice and outline what steps Amazon intends to take to ensure compliance with applicable U.S. medical device laws.