FDA Medical Device Establishment Registration & FDA FURLS Regulations

Our team of experts can help with your FDA establishment registration for medical devices. The registration of a medical device establishment is a two-step process. First you must pay the annual registration user fee. Once you have paid the fee, the registration process can be finalized.  Check out our ultimate guide for FDA Establishment Registration for more information.

FDA establishment registration

Why is the Medical Device Facility Registration Required? When to seek FDA FURLS Certification?

Registering medical device establishments  with the FDA annually is a must for every domestic and foreign manufacturer and initial distributor or importer of medical devices. It is obligatory for every importer of medical devices to the US to provide the FDA with the medical device facility establishment number for foreign manufacturers and importers/distributors.

Failure to do this results in delay or refusal of medical devices. Registering establishments or facilities with FDA is known as establishment registration.

What is FDA FURLS?

FURLS is an acronym that stands for FDA Unified Registration and Listing System. It is a system created by the FDA to help applicants register through an online system and make electronic submissions. With FURLs, you can view and edit your applications even after submission. 

The Food and Drug Administration (FDA) Furls regulation is a federal law that provides standards for the sale and manufacture of products to protect against contamination, spoilage, or product tampering. All companies selling products online must comply with the regulations outlined by the FDA Furls regulations if they want to remain compliant. This includes requirements related to labeling, packaging, and other safety-related measures.

FDA Establishment Registration

Medical Device Facility FDA Establishment Registration

Register your Medical Device Establishments through the FDA’s Unified Registration and Listing System (FURLS)! Things you need to know include:

As an owner or operator, having a valid login ID and password to access the FURLS is a must

As an owner or operator, you must obtain an annual registration

FDA establishment registration

In case of official correspondent, owner or operators must create a separate sub-account for any communication

FDA has established FURLS to advance electronic submissions

How do I register my Medical Device?

To register a new medical device, you must submit an application with the FDA. You will need to provide detailed information about the device, such as its intended use, manufacturing processes, materials, labeling, packaging, and instructions for use. Once the FDA has reviewed your application, you’ll receive approval to market your product.

Register and List Medical Device
How long does it take to register or list a Medical Device?

If you’re interested in selling your medical device, you should first determine whether it’s eligible for sale under the FD&C Act. This means that your device meets certain requirements, such as being safe and effective. Then, you must apply to the FDA to list your device. After the FDA approves your application, you can begin advertising your device.

It takes approximately two years to register a new device with the FDA. Once registered, it can take up to three months to complete an initial review of your device. You will need to submit additional information after the initial review. A final review usually takes another six months.

How are products regulated by the FDA FURLS?

Products regulated by the FDA are subject to strict safety testing, labeling, and packaging requirements. All products must meet specific standards for quality, safety, cleanliness, product origin, and dosages. The FDA Furls regulations also require companies to provide information about the manufacturing process and any potential health hazards associated with the product. Companies must provide complete ingredient lists with allergen declarations as well as instructions for proper storage and use of the product.

FDA FURLS certification
FDA FURLS product labelling
Which products require FDA FURLS Certification?

Any product purposefully intended for a medical purpose—including drugs, radiation-emitting devices such as x-ray machines and laser pointers, and items that could potentially violate the public health—are subject to FDA regulations. This includes food, supplements, cosmetics, household cleaners, medical devices, over the counter medications, medical treatments and services, etc. Companies must ensure that all products in their inventory meet FDA standards before they can be sold online or in stores.

What are the FDA FURLS product labelling requirements?

Businesses are responsible for labeling products in accordance with FDA rules. This includes making sure each product is accurately labeled, clearly listing ingredients and any health or safety warnings. It’s also important to include the source of the product if it contains an ingredient not typically used in the US or distributed by a foreign supplier. Companies should make sure labels provide consistent information about products, including nutritional facts for foods and drugs, and identify any medical devices as such.

Additionally, businesses must keep records of any adverse events that occur as a result of their products. These records can help the FDA trace any potential problems and should include reports of issues related to both digital marketing messages and products. Companies should also review digital marketing plans to identify areas they could improve, such as making sure campaigns conform to FDA rules.

Register and List Medical Device

Requirements for Medical Device Establishment Registration

Medical device establishment registration can be a complicated process. Our consultant can help you understand and meet all the necessary requirements!

Identify the Appropriate Level of Regulatory Control.

Gather Necessary Documentation and Documentation.

FDA UDI and GUDID 510k Medical Device

Fill Out the Establishment Registration Application Form to Completion.

Submit Completed Form and Supporting Documents & monitor application progress as it's reviewed.

Medical Device FDA Establishment Registration

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