U.S. Agent Responsibilities
The U.S. Agent must reside in the United States or maintain a business in the United States. The responsibilities of the U.S. Agent include:
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Assisting FDA in communications with the foreign establishment.
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Responding to questions concerning the foreign establishment’s devices that are imported or offered for import into the United States.
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Assisting FDA in scheduling inspections of the foreign establishment.
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If FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the U.S. Agent, and that action is considered equivalent to providing the same information or documents to the foreign establishment.
U.S. Agent Services
A.P. Lyon has years of experience serving as U.S. Agent to foreign establishments and is committed to providing first-class service to its customers.
FDA Facility Registration Services
Establishments involved in the production and distribution of medical devices intended for commercial distribution in the United States are required to register annually with the FDA. Most establishments required to register are also required to list the devices and the activities performed on those devices at the establishment. Whether you have a single facility or multiple facilities to register with the FDA, A.P. Lyon will help guide you through the entire process.
FDA FURLS Database Data Entry
A.P. Lyon provides medical-device registration and listing services for customers with one product or thousands. We work with clients to identify and gather the required information for the FDA Unified Registration and Listing System (FURLS) and Device Registration and Listing Module (DRLM). We enter the information and provide a Certification of Data Entry referencing the submitted data. Each certification is approved and signed by a qualified A.P. Lyon quality-assurance representative. Our goal is to earn our clients’ trust by handling their medical-device listing needs so they can focus on their products and services.
Device Registration and Listing Requirements
All proprietary names under which a device is marketed must be reported when the device is first listed and during annual registration and listing updates.
Combination products consisting of a device and a biological product or drug must be identified as combination products, including the applicable combination-product type.
Contract manufacturers and sterilizers of finished devices must register and list, whether they distribute the device or return it to the manufacturer or specification developer.
Initial importers must identify the manufacturers of the devices they import.
Foreign establishments exporting devices or offering devices for export to the United States must identify all known U.S. importers.
A device must be listed by the manufacturer, specification developer, single-use-device reprocessor, remanufacturer, or repacker/relabeler 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 use the “Complaint File Establishment” type.