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.

QNET Export Finance Services LLC offers FDA U.S. Agent services that meet FDA 21 CFR 807.40 requirements as follows:

• Maintain a place of business in the United States including a telephone, email and fax.
• Accept all calls from the FDA regarding the client or its devices and reports to client within TWO (2) business days, Saturday,Sunday and U.S. recognized holidays excluded, a summary of said calls.
• Assist FDA, as contemplated by the Regulation, in communications with the client.
• Provide liaison between FDA and client in scheduling inspection(s) of the facilities of the company.
• Assist client in filing FDA Form 2891 with FDA, which meets FDA requirement for registration and identifies QNET as the United States Agent.
• Respond to questions, either by direct response or by commitment to provide a timely response following consultation with client, regarding products that are imported or offered for import into the United States.

QNET Export Finance Services LLC offers a separate agreement for the following services:

• Provide assistance in any way regarding the preparation of 510(k) or filing of any documents with FDA regarding pre market approvals or supplements, pre market notifications, investigational device exemptions.
• Provide any regulatory advice on any matters of conflict with FDA or advise company on issues of compliance with Quality System Regulations as described at 21 CFR 820.
• Provide any services relative to the administration of FDA required reports under the Medical Device Reporting Regulation found at 21 CFR 803 except as necessary to facilitate communications between the FDA and Company as contemplated by the Regulation.