All medical device manufacturers, repackers, relabelers, specification developers, and initial importers must comply with FDA regulations for establishment registration and device listing under 21 CFR Part 807. Annual registration ensures FDA oversight of facilities marketing devices in the United States, while device listing identifies each medical device available in the market.

At XPRO AMERICA, we provide comprehensive support for domestic and foreign companies to maintain full compliance with FDA medical device registration and listing requirements, minimizing risk and streamlining regulatory obligations.

Key Services:

• Establishment Registration: All U.S. and foreign entities involved in manufacturing, repacking, relabeling, specification development, or initial import of medical devices must register annually with the FDA. XPRO AMERICA manages the registration process to ensure timely and accurate submissions.
• Device Listing: Each marketed medical device must be listed with the FDA, including device classification and intended use. Our team prepares and maintains comprehensive device listings to meet FDA requirements.
• Annual Renewal & Updates: FDA requires annual updates to both establishment registration and device listings. XPRO AMERICA monitors deadlines and facilitates seamless renewal and modifications, avoiding regulatory penalties.
• Regulatory Guidance & Compliance Strategy: We assist companies in determining proper device classification, reviewing registration requirements, and aligning documentation with FDA expectations to ensure ongoing compliance.
• Inspection Readiness: Maintaining accurate registrations and device listings is crucial for FDA inspections. Our services include audit support and documentation review to prepare for regulatory assessments.

Why Choose XPRO AMERICA?

• Expertise in 21 CFR Part 807 medical device registration and listing requirements.
• Comprehensive support from initial registration to annual renewals and updates.
• Ensures accurate device classification, listing, and regulatory compliance.
• Minimizes FDA enforcement risk and facilitates uninterrupted market access.

Partnering with XPRO AMERICA ensures that medical device manufacturers, importers, and other stakeholders remain compliant with FDA regulations for establishment registration and device listing, maintaining regulatory confidence, inspection readiness, and market access.

XPRO AMERICA supports FDA medical device establishment registration, device listing, and annual compliance for domestic and foreign manufacturers.