US Agent to the FDA & Regulatory Consulting

A Federal Food and Drug Agency Agent ( FDA US Agent) is the representative for Medical Devices and IVDs companies without a presence in the United States. Companies without a presence in the U.S. are required by the FDA to appoint a Registered FDA US Agent. Your FDA US Agent must be a United States Resident or maintain a place of business within the United States. The U.S. agent cannot use a post office box as an address. The U.S. agent cannot use just an answering service. They must be available to answer the phone or have an employee available to answer the phone during normal business hours. Without a U.S. facility, you will be unable to register your facility, list your products, or submit the FDA marketing authorization applications without designating a U.S. Agent.

• FDA QMSR Rule Gap Assessments

With the new FDA Quality Management System Regulations (QMSR) coming into effect on February 2, 2026, we offer comprehensive gap analyses to facilitate the transition from 21 CFR 820 to ISO 13485.

• 510(k) & De Novo Strategy and Preparation

Leverage FDA pre-submissions to address critical points in advance.
We provide:

1. Strategic planning for 510(k) and De Novo submissions;
2. Preparation of comprehensive submission dossiers;
3. Consulting on regulatory pathways for expedited approvals.

• Support with FDA Interactions

Engage effectively with the FDA throughout the product lifecycle.
Our support includes:

1. Preparation for pre-submissions;
2. Assistance during FDA inspections;
3. Ongoing communication to address regulatory inquiries.