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FDA FURLS System | Medical Device Registration

Device Registration and Listing

FDA Furls Database Data Entry

We offer product registration services to our customers. Whether it is a single product or thousands, we will get the job done in accordance with the FDA medical device listing requirements.

A.P. Lyon will work with you identify and gather all required information to enter into FDA FURLS System / Device Registration Listing Module (DRLM). We will load the information into the FDA Furls System and provide our clients with a Certification of Data Entry referencing all the data entered. Each certification is approved and signed by a qualified A.P. Lyon quality assurance representative.

Our goal is to earn the trust of our clients to handle all their medical device listing needs so they are free to focus on their products and services.

To learn more please contact us at info@aplyon.com

Device Registration and Listing Requirements

The following medical device listing requirements became effective on October 1, 2012. 
  • All proprietary names under which a device is marketed must be reported, at a minimum, when a device is first listed and during the annual update of registration and listing information.
  • Combination products – products comprising a device and a biological product or a drug – must be identified as a combination product and the type of combination product (for example, convenience kit, prefilled drug delivery device, etc.) must be selected from the list displayed in the FDA Unified Registration and Listing System (FURLS).
  • All contract manufacturers and sterilizers of finished devices must register and list regardless of whether they put the device into commercial distribution or return the device to the manufacturer or specification developer.
  • Initial importers must identify the manufacturers of the devices they are importing.
  • Foreign establishments that are exporting devices or offering devices for export to the United States must identify all known U.S. importers of their devices.
  • A device must be listed by the manufacturer, specification developer, single-use device reprocessor, remanufacturer, or re-packer/re-labeler before a foreign exporter, contract manufacturer, or contract sterilizer can list it.
  • Establishments that only handle complaints and previously registered as manufacturers or specification developers should change their establishment type to “Complaint File Establishment.”

US Agents

We have years of experience serving as US Agent to foreign establishments and are committed to providing first in class service to our customers
Learn More

Facility Registration

Whether you have a single facility or multiple facilities to register with the FDA we are here to help walk you through the entire process.
Learn More

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  • HOME
  • STORE
    • ISO 13485 QUALITY SYSTEMS >
      • MANUFACTURING PLUS
      • MANUFACTURING SYSTEM
      • DESIGN PLUS SYSTEM
      • DESIGN SYSTEM
      • BASE PLUS SYSTEM
      • BASE SYSTEM
      • ISO 13485 Quality Management System Manual
    • ISO 13485 PROCEDURE BUNDLES >
      • ISO 13485 Document Control Procedure Bundle
      • Design Control Procedures Bundle
      • Risk Management Procedures Bundle
      • ISO 13485 Process Validation Procedure Bundle
      • Medical Device Sterilization Procedure Bundle
      • Medical Device Labeling Bundle
      • Medical Device Software Procedure Bundle
      • Clinical Evaluation Procedure Bundle
      • Cleanroom Procedure Bundle
      • Complaint Handling Procedures Bundle
    • ISO 13485 QUALITY SYSTEM PROCEDURES >
      • ISO 13485 DOCUMENTATION REQUIREMENTS PROCEDURES >
        • Engineering Change Notice Procedure
        • Document Control Procedure
        • Record Retention Procedure
      • ISO 13485 MANAGEMENT RESPONSIBILITIES PROCEDURES >
        • Management Review Procedure
      • ISO 13485 RESOURCE MANAGEMENT PROCEDURES >
        • Training Procedure
        • Facility Inspection Procedure
        • Respiratory Protection Procedure
        • Biohazard Procedure
        • Lockout - Tagout Procedure
        • Preventive Maintenance Procedure
      • ISO 13485 PRODUCT REALIZATION PROCEDURES >
        • ISO 13485 DESIGN - DEVELOPMENT PROCEDURES >
          • Design Control Procedure
          • Customer Requirements Validation
          • Human Factors - Usability Engineering Procedure
          • Design Review Procedure
          • Risk Management Procedure
          • Design Transfer Procedure
          • Shelf Life Procedure
          • Technology Transfer Procedure
          • Design Verification - Validation Procedure
          • Design Risk Management Procedure
          • Design Analysis Procedure
          • Biocompatibility - Toxicity Testing Procedure
          • ISO 13485 Label Review and Approval Procedure
          • Unique Device Identification Procedure
          • Software Development Procedure
          • Software Clinical Evaluation Procedure
          • Clinical Evaluation Procedure
          • Clinical Investigation Procedure
          • Product Performance Specification Procedure
          • CE Marking Procedure
        • ISO 13485 PURCHASING PROCEDURES >
          • Supplier Management Procedure
          • Purchase Order Procedure
        • ISO 13485 PRODUCTION - SERVICE PROVISION PROCEDURES >
          • Cleanroom Design and Validation Procedure
          • Environmental Controls Procedure
          • Controlled Environment Cleaning Procedure
          • Sterile Load Preparation - Release Procedure
          • Gamma Irradiation Sterilization Validation Procedure
          • Ethylene Oxide EO Sterilization Validation Procedure
          • Software Validation Procedure
          • Installation Qualification (IQ) Procedure
          • Medical Device Process Validation
          • Validation Protocols - Reports Procedure
          • Process Risk Management Procedure
          • Device History Record
          • Identification Procedure
          • Lot Inspection Procedure
          • First Article Inspection Procedure
          • Line Clearance Procedure
          • ISO 13485 Contract Review Procedure
        • ISO 13485 CONTROL MONITORING MEASUREMENT DEVICES PROCEDURES >
          • Calibration System Procedure
      • ISO 13485 MEASUREMENT ANALYSIS IMPROVEMENT >
        • Complaint Handling Procedure
        • Complaint Trending Procedure
        • Nonconforming Material Procedure
        • Corrective - Preventive Action Procedure
        • Internal Audit Procedure
        • Medical Device Report MDR Procedure
        • Product Hold Procedure
        • Remedial Action - Recall Procedure
        • Statistical Techniques Procedure
        • Post Market Surveillance Procedure
        • Post Market Clinical Follow Up Plan
        • Post Market Clinical Follow Up Evaluation Report
        • Periodic Safety Update Report (PSUR) Procedure
        • Vigilance Procedure
        • Failure Investigation Procedure
    • VALIDATION PROTOCOLS >
      • Clinical Investigation Report
      • Clinical Investigation Plan
      • Ethylene Oxide (EO) Product Adoption
      • Accelerated Aging Study
      • Injection Mold Validation Procedure
      • Medical Device Software Development Plan
      • Final Cleaning Orthopedic Implants
      • Bar Sealer Operational Qualification OQ Protocol
      • Bar Sealer Performance Qualification PQ Protocol
      • Bar Sealer Qualification Protocol Bundle OQ - PQ
      • Tray Sealer Operational Qualification OQ Protocol
      • Tray Sealer Performance Qualification PQ Protocol
      • Tray Sealer Qualification Protocol Bundle OQ - PQ
      • 4 Sided Sealer Operational Qualification OQ Protocol
      • 4 Sided Sealer 4SS Performance Qualification PQ Protocol
      • 4 Sided Sealer Qualification Protocol Bundle OQ - PQ
    • CONTRACTS - AGREEMENTS >
      • Medical Device Quality Agreement | US
      • Medical Device Quality Agreement | EU
      • Master Consulting Agreement
  • CONSULTING
    • QUALITY SYSTEM INSTALLATION - TRAINING
    • FDA QSIT AUDIT PREPARATION
    • DESIGN - PROCESS VALIDATION
  • FDA US AGENTS
    • US AGENTS
    • FACILITY REGISTRATION SERVICES
    • FDA FURLS DATABASE DATA ENTRY SERVICES
  • ABOUT
  • CONTACT