FDA FURLS System | Medical Device Registration

FDA Furls Database Data Entry

We offer product registration services to our customers. Whether it is a single product or thousands, we will get the job done in accordance with the FDA medical device listing requirements.

A.P. Lyon will work with you identify and gather all required information to enter into FDA FURLS System / Device Registration Listing Module (DRLM). We will load the information into the FDA Furls System and provide our clients with a Certification of Data Entry referencing all the data entered. Each certification is approved and signed by a qualified A.P. Lyon quality assurance representative.

Our goal is to earn the trust of our clients to handle all their medical device listing needs so they are free to focus on their products and services.

To learn more please contact us at info@aplyon.com

Device Registration and Listing Requirements

The following medical device listing requirements became effective on October 1, 2012. 

• All proprietary names under which a device is marketed must be reported, at a minimum, when a device is first listed and during the annual update of registration and listing information.
• Combination products – products comprising a device and a biological product or a drug – must be identified as a combination product and the type of combination product (for example, convenience kit, prefilled drug delivery device, etc.) must be selected from the list displayed in the FDA Unified Registration and Listing System (FURLS).
• All contract manufacturers and sterilizers of finished devices must register and list regardless of whether they put the device into commercial distribution or return the device to the manufacturer or specification developer.
• Initial importers must identify the manufacturers of the devices they are importing.
• Foreign establishments that are exporting devices or offering devices for export to the United States must identify all known U.S. importers of their devices.
• A device must be listed by the manufacturer, specification developer, single-use device reprocessor, remanufacturer, or re-packer/re-labeler before a foreign exporter, contract manufacturer, or contract sterilizer can list it.
• Establishments that only handle complaints and previously registered as manufacturers or specification developers should change their establishment type to “Complaint File Establishment.”

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US Agents

We have years of experience serving as US Agent to foreign establishments and are committed to providing first in class service to our customers

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Facility Registration

Whether you have a single facility or multiple facilities to register with the FDA we are here to help walk you through the entire process.

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