U.S. Agent Service
EMPOWER is your trusted partner, acting as a U.S. Agent to represent foreign medical device companies before the FDA.
What’s Included?
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Handling the electronic submission of your establishment's information using the FDA Unified Registration and Listing System (FURLS) to ensure proper registration.
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Acting as the direct point of contact for the FDA, responding to inquiries about your medical devices, and coordinating the scheduling of any necessary FDA inspections.
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Serving as an immediate contact for the FDA in situations where the agency cannot reach the foreign establishment directly or quickly.
Regulatory Synergy for Market Success
Maximize your U.S. market strategy by integrating our U.S. Agent service with our suite of regulatory solutions. Together, they can help you ensure FDA compliance and a streamlined path to market entry.
Explore our other services here.
Get Started
To get started with EMPOWER as your U.S. Agent, fill out the following form and you will be contacted within 48 hours. We look forward to partnering with you!