Hello @Seller_eUNrr84LtFWXl,

Thanks for posting your inquiry. For Class I medical devices like Silicone Scar Sheets, registration with the FDA is generally required for the manufacturer or initial distributor. However, if you're a brand owner in Brand Registry, you have a couple of options:

1. Register your brand directly with the FDA: This involves registering your facility and listing your device with the FDA.
2. Have the manufacturer list your brand: The manufacturer can list your brand under their company with the device listing code. This is often a simpler approach for brand owners who are not directly manufacturing the product.

It’s important to note that most Class I devices are exempt from the 510(k) clearance process, but they still need to comply with general controls and labeling requirements.

Whichever option you choose, ensure that your product meets all FDA labeling requirements, including:

• Brand name
• Device name
• Manufacturer’s name and address
• Intended use
• Adequate directions for use

Additionally, when listing your product on Amazon, make sure to comply with Amazon’s policies for medical devices, including accurate product descriptions and appropriate marketing claims.

Regards,

- Manny