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U.S. Agents | FDA

    https://www.fda.gov/medical-devices/device-registration-and-listing/us-agents
    Please note that the U.S. agent has no responsibility related to reporting of adverse events under the Medical Device Reporting regulation (21 CFR Part 803), or submitting 510(k) Premarket ...

US Agent Service for FDA Registration cost - RQMIS

    https://www.rqmis.com/services/us-agent-and-representative-service
    As an FDA US Agent (FDA Official Correspondent), RQMIS can assist your medical devices with FDA registration. FDA Medical Device User cost - Fiscal Year 2023. 2023 …

FDA US Agent Medical Devices in USA - Emergo

    https://www.emergobyul.com/services/us-fda-agent-representation-medical-device-and-ivd-companies
    Appoint Emergo as your US FDA agent. Since 1997, Emergo has served as an official US Agent for 180+ medical device and IVD companies from 30+ countries worldwide. Here …

US Agent and Representation Services — Americas Actual

    https://www.americasactual.com/us-agent
    FDA US Agent Service. Americas Actual US Agent Fee: $750 per year. Foreign manufacturers must identify a US Agent to manage communication with the FDA and be …

US FDA Agent Services for Foreign …

    https://www.fdabasics.com/our-service/us-fda-agent/
    We offer US FDA Agent services to clients around the world, building on over twenty years of experience. We provide a cost-effective, high-quality service, our US …

US FDA Agent Services and Fees For Food, Drug and …

    https://www.fdahelp.us/fda-registration-agent.html
    The US FDA agent has no responsibility to report adverse events under the Medical Device Reporting regulation. Please visit our fee page for the updated fee schedule at FDA …

FDA Fees - FDA Registration & U.S. Agent Services

    https://www.itbholdingsllc.com/fda-fees/
    USER FEES. Paid to the U.S. Treasury. $6,493.00 | Medical Device Establishment Registration (FY 2023) $16,119 – $24,178 | Over-The-Counter Monograph …

US Agent for Medical Device Companies - FDABasics

    https://www.fdabasics.com/us-agent-for-medical-device/
    Our fee for U.S Agent services is $ 299 for 12 months. We do not hike prices during annual renewal or charge any other hidden fees. All prices are upfront. We …

FDA U.S. Agent Services - Accurate FDA Consultants

    https://www.accuratefdaconsulting.com/fda-u-s-agent-services-2
    The U.S. Agent Agreement is for a period of one year at a fee of $495. Should you need additional services, Accurate can provide regulatory, testing, preclinical, clinical, and …

U.S. Agent Services for the Pharmaceutical …

    https://www.rcainc.com/us-agent-services/
    The responsibilities of the U.S. Agent are limited and include: Assisting FDA in communications with the foreign establishment. Responding to questions concerning the …



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