What is the FDA?
The Food and Drug Administration is the US federal agency responsible for supervising the product safety. The FDA must approve of certain types of products in order to make sure that they do not pose risks to consumers' health.
What types of products are regulated by the FDA?
The main product types covered by the FDA regulation are: food, medical devices, electronic devices etc. Please refer to the main page of the Food & Drug Agency (Products We Regulate section) to see the full list of the product categories.
To learn more information on approvals of certain types of the FDA-Regulated Products, please refer to this page.
The FDA and medical devices
This FDA guidance will help you figure out applicable requirements for the medical devices and check whether your product falls into the category of medical devices or not.
If you had previously been selling medical devices in the US market and your product was recalled, you must not sell such products on Joom. You can check the list or the recalled medical devices on the FDA official resources page.
Then FDA and medical masks
Not all face masks are a subject of the FDA regulations. If they are of general use (protection equipment, intended for use for construction and other industrial purposes), they do not fall into the medical device category. If they are for medical purposes or surgical masks, they are qualified as medical devices and are regulated by the FDA.
To learn the FDA requirements for certain types of masks, please refer to this page.
If masks fall into the category of medical devices (for example, it is a surgical mask or N95 masks intended for medical use), you must comply with the premarket notification (510k) requirements.
We may ask you to provide the information related to the masks you sell on Joom in order to verify whether premarket notification requirements are met or not.
Example of premarket notification documents.
We can also require you to provide the FDA establishment registration and device listing certificate.
The FDA and cosmetics products
According to the FDA, cosmetic products and their ingredients (other than color additives) do not need the agency's approval before being sold. Cosmetic companies are not required to register with FDA, but cosmetics do have to be safe for their intended use.
Please note that some cosmetic products might be qualified as drugs, it will lead to the obligation to comply with the FDA requirements to the drug products and can make it impossible to sell such products on Joom.
To learn the FDA requirements for certain types of cosmetic products, please refer to this page.
The FDA and radiation-emitting electronic products
Products such as: components for the audio, video and computer equipment (CD, DVD, Blue Ray, HD (High Definition)), or other optical disk players and recorders, bar code readers, printers, copiers, fax machines fall into the category of radiation-emitting electric products and are subjected to FDA regulation.
Examples of such products can be found here.
How to get the FDA approval?
We advise you to contact a company or an agency that can consult you on the FDA-related matters and can help you identify applicable regulations. Please note that you are fully and solely responsible for compliance with the US laws and regulations, including those related to FDA approval. We can ask you to provide documents confirming that your products comply with mandatory requirements at any time.
Misusing of "FDA approved" is strongly prohibited
- Merchants shall not use "FDA approved" or similar wordings in a product's description, images or other details provided in the product card if the product either doesn't require the FDA approval or the merchant hasn't received the approval.
- The FDA logo must not be used on the products themselves (shall not be used on the products labelling). This would mean that the product is endorsed by FDA. Manufacturers falsely using FDA’s logo on their product labelling may have to face civil or criminal liability. If products require the FDA approval labelling is permitted only after officially receiving the legit approval for the product.
More information on how to properly use the "FDA approved" logos can be found here.
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