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Summary

You must complete FDA Registration and Listing to establish your legal presence in the FDA database and obtain authorization to manufacture, import, or distribute medical devices in the United States. This mandatory process includes establishment registration, device listing, and maintenance of current information that enables FDA oversight and regulatory communication throughout your device’s commercial lifecycle.

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Regulatory Context

Under 21 CFR Part 807 (Establishment Registration and Device Listing), you must comply with:
  • Annual registration per Section 807.20 for all device establishments
  • Device listing per Section 807.25 for all marketed devices
  • US Agent designation per Section 807.40 for foreign establishments
  • Registration renewal per Section 807.22 annually between October 1 and December 31
  • Premarket notification per Section 807.81 for most Class II devices before marketing
Special attention required for:
  • Foreign establishments must designate qualified US Agent for FDA communications
  • Software as Medical Device classification and appropriate product code selection
  • Combination products requiring coordination with other FDA centers
  • Export-only manufacturers having different registration requirements than domestic marketers

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Overview

FDA Registration and Listing establishes the fundamental regulatory foundation for medical device marketing in the United States by creating your official presence in FDA databases while enabling regulatory oversight, communication, and market surveillance activities. This essential regulatory process transforms your organization from unrecognized entity to officially registered medical device establishment with specific rights and obligations under FDA jurisdiction. Establishment Registration Process creates your official FDA presence by registering your company as a medical device establishment with appropriate activity designations and contact information. Registration process requires completion of electronic registration through FDA systems including provision of complete business information, designation of establishment activities such as manufacturing or importing, and establishment of communication protocols with FDA. Foreign establishments must additionally designate qualified US Agents who serve as primary FDA communication points and have authority to represent the company in regulatory matters including inspection scheduling and regulatory correspondence. Device Listing and Classification establishes official recognition of your specific medical devices within FDA databases while confirming appropriate regulatory classification and product codes. Device listing requires accurate device identification including proprietary names, common names, and intended use statements that clearly define device scope and limitations. Classification activities include determination of appropriate FDA product codes based on device technology and intended use, confirmation of device class designation that determines regulatory requirements, and identification of applicable predicate devices for substantial equivalence demonstration when required. US Agent Designation and Management ensures effective FDA communication for foreign establishments through qualified representatives who understand FDA requirements and can facilitate regulatory interactions. US Agent management requires selection of qualified individuals or organizations with appropriate FDA knowledge and authority to represent your company, establishment of clear communication protocols and responsibilities including inspection coordination and regulatory correspondence, and maintenance of current contact information and availability during normal business hours for FDA interactions. Premarket Submission Coordination aligns registration and listing activities with required premarket submissions including 510(k) clearance, PMA approval, or De Novo classification while ensuring regulatory pathway optimization. Submission coordination requires understanding of device classification requirements that determine premarket submission needs, preparation of substantial equivalence demonstrations for 510(k) submissions including predicate device identification and comparison, and coordination of submission timing with registration and listing activities to enable efficient market entry. Annual Renewal and Maintenance ensures continued registration validity through timely renewal and updates while maintaining current information in FDA databases throughout the commercial device lifecycle. Renewal activities include completion of annual registration renewal between October 1 and December 31, updates to device listings when significant changes occur including new device versions or modifications, and maintenance of current contact information and establishment activity designations that reflect actual business operations. Design History File Integration connects FDA registration requirements with comprehensive design control documentation that supports premarket submissions and ongoing regulatory compliance. DHF integration requires compilation of complete design control records including design inputs, outputs, reviews, verification, validation, and transfer documentation that demonstrates systematic device development. Integration activities ensure that DHF contents support registration requirements while providing comprehensive evidence for premarket submissions and regulatory inspections. Software Device Considerations addresses unique registration requirements for software medical devices including appropriate classification, product code selection, and regulatory pathway determination. Software considerations require understanding of Software as Medical Device (SaMD) classification frameworks, selection of appropriate product codes that reflect software functionality and intended use, and coordination with FDA software guidance requirements including lifecycle documentation and cybersecurity considerations that affect registration and submission requirements. Post-Market Reporting Integration establishes connections between registration requirements and ongoing post-market surveillance obligations including adverse event reporting and periodic reporting. Reporting integration requires implementation of Medical Device Reporting (MDR) procedures for adverse events, malfunctions, and deaths associated with registered devices, establishment of post-market surveillance systems that monitor device performance and safety, and coordination with registration maintenance activities that ensure continued compliance with FDA requirements. Multi-Product and Multi-Site Management addresses complexities of managing registration and listing for organizations with multiple devices, manufacturing sites, or business activities while ensuring comprehensive compliance and efficient administration. Multi-site management requires coordination of registration activities across different establishments and locations, management of device listings for product portfolios with varying regulatory requirements, and implementation of systematic procedures that ensure consistent compliance across all registered activities and locations. Regulatory Communication and Inspection Readiness ensures effective interaction with FDA through proper registration channels while maintaining readiness for regulatory inspections and inquiries. Communication readiness requires establishment of systematic procedures for responding to FDA correspondence and inspection requests, maintenance of registration documentation and supporting materials in readily accessible formats, and implementation of internal audit procedures that ensure ongoing registration compliance and inspection readiness. Your FDA Registration activities must demonstrate systematic regulatory compliance while establishing the legal foundation necessary for confident US market entry and ongoing commercial success. Well-executed registration processes provide FDA with accurate information for effective oversight, enable efficient regulatory communication and submission review, and establish the compliance foundation for successful long-term market presence through demonstrated adherence to fundamental FDA requirements and professional regulatory management.