FDA Compliance
A core QNR service, with both standard and customized solutions available, the QNR team can serve as U.S. Agent, Official Correspondent, establish and maintain your business in compliance with FDA requirements.
FDA Compliance
The QNR team has years of experience helping medical device companies establish and grow their business while maintaining FDA compliance.
As a core service, QNR offers standard FDA compliance packages to customers, including US Agent, US Official Correspondent, and comprehensive FDA compliance services. The QNR team can help support the successful registration and listing for your device establishment(s) as required by the FDA, and support ongoing compliance activities as you grow your business.
Please read below for background and detailed descriptions of some core FDA compliance services we provide. With each of these standard services, your establishment will have an experienced consultant at its side to ensure and that your establishment remains in a continuous state of compliance.
FDA Compliance Services:
The Details
FDA U.S. Agent
Per FDA requirements, any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States must identify a United States agent (U.S. Agent) for that establishment. The QNR team can support your business in this capacity to serve as point of contact with the FDA.
There are certain requirements that the U.S. Agent needs to meet, including that the U.S. Agent must either reside in the U.S. or maintain a place of business in the U.S. The QNR team resides domestically within the U.S. to meet that requirement.
The responsibilities of the U.S. Agent include the following:
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Assisting the 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 and
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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 such an action shall be considered to be equivalent to providing the same information or documents to the foreign establishment.
Please note that these service as U.S Agent are limited in comparison to the other packages, and is primarily an in-country point of contact for your establishment. The standard package rate includes the following services:
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U.S. Agent support setup, including confirm of the QNR team's consent to act as a representative/liaison on behalf of the foreign establishment.
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Estimated miscellaneous support throughout the year.
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Customized packages and flexible payment options are also offered.
FDA Official Correspondent
Per FDA definition, an Official Correspondent is defined as:
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The person designated by the owner/ operator of an establishment responsible for the annual registration of the establishment and the device listing. The Official Correspondent also receives correspondence from the FDA involving the owner/operator and any of the firm’s establishments.
The Official Correspondent is responsible for the registration and listing information for each establishment to which he/she is assigned. With this package, the QNR team will serve in this capacity for your establishment.
The Official Correspondent can:
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Create new registrations and listings
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Make changes, updates and cancellations to registrations and listings that have been assigned to them
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Add their establishment(s) to listings previously entered for the owner/operator
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View registration and listing information for the establishments which have been created by or assigned to them
As part of these services, the QNR team will be assigned a subaccount by your establishment within the FDA FURLS database to perform these services throughout the year. The standard package rate includes the following services:
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Official Correspondent support, including keeping registration and listing information current to ensure the compliance of your establishment.
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Estimated miscellaneous support throughout the year.
Customized packages and flexible payment options are also offered.
FDA Compliance: Comprehensive Compliance Package
With this package, the QNR team will provide comprehensive services on behalf of your business, serving as both U.S. Agent and Official Correspondent for your business as needed to meet your business needs. QNR will manage your FDA account, paperwork and communications, in an all-in-one package so you can focus on other aspects of your business.
The FDA compliance package includes the following services:
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Serve as U.S. Agent and/or Official Correspondent for your business as needed (description of services in sections above)
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Manage the FDA FURLS database on your behalf
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Supports the annual registration for your establishment
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Provides facility registration support, including registering facilities, changing registration information, cancel/deactivate/reactivate a facility registration, and changing the official correspondent.
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Supports transfer of ownership of a facility (through merger/acquisition)
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Supports listing creation, change, deactivation and/or reactivation.
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Supports addition/replacement of proprietary names or importers to listings.
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Supports U.S. Agent confirmation, view and/or updates
Customized packages and flexible payments options are also offered.