Who Must Register FDA If You Import and Sell First Aid Kits in the US?

The Food and Drug Administration (FDA) is an agency tasked with the responsibility of protecting the public's health by ensuring that medical devices, biological products, and veterinary and human drugs are safe and effective.

The FDA requires owners or operators of establishments involved in the production and distribution process of medical kits intended for commercial distribution in the United States to register, list, and pay the fee to the FDA annually. The process is known as establishment registration.

The definition of a first aid kit certainly fits into that of a medical device provided by section 201(h) of the Food, Drug, and Cosmetic Act.

Therefore, the manufacturers of first aid kits are required to register, list, and pay the fee.

The FDA defines a manufacturer as any establishment that makes biological, physical, chemical, or other procedures, and makes any article that meets the device definition in Section 201(h) of the Federal Food, Drug, and Cosmetic Act.

The FDA also requires the importer (buyer) to register, list, and pay the fee. The importer is required to get an initial FDA number, and failure of the importer to do so will result in the products being detained when they get to the United States or even returned to the manufacturer.

The FDA defines the buyer as any importer involved in furthering a device's marketing from a foreign manufacturer to the person who finally delivers or sells the device to the user or ultimate consumer. This importer, however, does not repackage, change the container, labeling, or wrapper of the device or device package. The importer must have a physical store with employees to ensure all imported items comply with FDA regulations.

However, work with a manufacturer that is highly experienced in the exportation of medical kits. They can help you handle the initial FDA number so that you do not have to pay for the FDA.

The FDA was authorized to collect the fee for the annual establishment registration for device establishments by Congress. The annual registration user fee for the 2021 fiscal year is $5,546. Your registration will only be considered to be complete when you have

• paid the annual registration user fee.

• electronically submit your registration and listing information.

• received a notification email from the FDA that you have met all the requirements.

Unless the FDA grants you a waiver, you must submit all your registration and listing information electronically.

All establishments to register with the FDA must first pay the user fee on the Device Facility User Fee website. When you have made the payment and gotten your Payment Identification Number (PIN)and Payment Confirmation Number (PCN), you can then proceed to complete your registration and listing requirements on the FDA's Unified Registration and Listing System (FURLS).

Conclusion

The registration and listing that these establishments are required to do by the FDA gives the FDA the location of these medical kits establishments and provides them with the list of manufactured devices. Knowing the exact location of these devices will increase the nation's chances of preparing for and responding to public health emergencies.

FAQs

What physical facility requirements exist for first aid kit importers?

The FDA requires importers to maintain a physical facility with employees who can ensure compliance with FDA regulations. This cannot be just a virtual office or mailbox. The facility should be able to receive, inspect, and handle returned or recalled products if necessary. The physical address is recorded in your FDA registration and may be subject to inspection.

If my first aid kit contains certain special medications, are there additional requirements?

Yes, if your first aid kits contain prescription drugs, controlled substances, or certain active ingredients, additional licenses or special requirements may apply. These products might be regulated by FDA's drug division rather than the medical device division, requiring more stringent compliance standards. Consult with a regulatory expert before importing such products.

How do I know if my first aid kit is considered a medical device by FDA?

Most first aid kits are classified as medical devices under Section 201(h) of the Food, Drug, and Cosmetic Act because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Even basic kits containing bandages, antiseptics, and over-the-counter medications fall under this definition and require proper registration and compliance.