FDA Registration And Listing

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Summary

FDA Registration and Listing is the mandatory process of registering your company as a medical device establishment and listing your medical devices with the Food and Drug Administration (FDA) before marketing them in the United States. This process establishes your legal presence in the FDA database and enables regulatory oversight of your devices.

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Why is FDA Registration and Listing important?

FDA Registration and Listing serves as the foundation for all medical device activities in the US market. Without proper registration, you cannot legally manufacture, import, or distribute medical devices in the United States. The process establishes your company in the FDA database, enables regulatory communication, and provides the FDA with essential information for market surveillance and safety monitoring. Registration also demonstrates your commitment to regulatory compliance and enables the FDA to conduct inspections and oversight activities when necessary.

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Regulatory Context

Under 21 CFR Part 807 (Establishment Registration and Device Listing):

• Annual registration required for all device establishments
• Device listing required for all marketed devices
• 510(k) clearance or PMA approval required before marketing most devices
• Registration renewal required annually between October 1 and December 31

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Guide

FDA Registration and Listing involves two distinct but related processes that must be completed before marketing your medical device in the United States. The process establishes your regulatory identity and provides the FDA with essential oversight information.

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Step 1: Establishment Registration

Company Information: Register your company as a medical device establishment using the FDA’s electronic registration system. Provide complete business information including legal name, physical address, business activities, and contact information. For software companies, clearly indicate your role as a device manufacturer.

US Agent Designation: If you’re a foreign establishment, you must designate a US Agent who serves as your communication point with the FDA. The US Agent must be physically located in the United States and have authority to represent your company in FDA matters. This person receives all FDA communications and must be available during normal business hours.

Registration Activities: Specify your establishment activities such as manufacturing, importing, or distributing medical devices. For software medical devices, select “Manufacture” as your primary activity. Include any contract manufacturing or sterilization activities if applicable.

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Step 2: Device Listing

Device Classification: Determine your device’s FDA product code and classification (Class I, II, or III). For software medical devices, common product codes include DQO (Software, Medical Device), LLZ (System, Physiological Monitoring), or device-specific codes based on your intended use.

Device Information: Provide detailed device information including proprietary name, common name, intended use, and product code. For software devices, include the software version and specify whether it’s standalone software or software in a medical device.

Predicate Device: If submitting a 510(k), identify your predicate device by name and 510(k) number. The predicate device must be legally marketed and substantially equivalent to your device in terms of intended use and technological characteristics.

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Step 3: Premarket Submission Requirements

510(k) Clearance: Most Class II devices and some Class I devices require 510(k) clearance before marketing. Submit your 510(k) application demonstrating substantial equivalence to a predicate device. Include comprehensive testing data, software documentation, and clinical evidence as required.

PMA Approval: Class III devices typically require Premarket Approval (PMA), which involves extensive clinical trials and comprehensive safety and effectiveness data. This process is significantly more complex and time-consuming than 510(k) clearance.

De Novo Classification: For novel devices without appropriate predicates, consider the De Novo pathway to establish a new device classification and create a predicate for future similar devices.

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Step 4: Annual Maintenance

Registration Renewal: Renew your establishment registration annually between October 1 and December 31. Failure to renew results in automatic cancellation of your registration and inability to market devices.

Device Listing Updates: Update your device listings whenever you make significant changes to device design, intended use, or manufacturing processes. Add new devices to your listing before marketing them.

Adverse Event Reporting: Implement Medical Device Reporting (MDR) procedures to report adverse events, malfunctions, and deaths associated with your device. Software devices must report software failures that could lead to patient harm.

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Example

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Scenario

You’ve developed a Class II software application for diabetes management that helps patients track glucose levels and provides insulin dosing recommendations. You need to complete FDA registration and listing before launching in the US market.

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FDA Registration and Listing Process Example

Step 1: Establishment Registration

Company: DiabetesTracker Solutions LLC
Address: 123 Innovation Drive, Austin, TX 78701
Business Activity: Medical Device Manufacturer
Registration Type: Domestic Establishment
FDA Registration Number: 12345678 (assigned by FDA)

Step 2: Device Listing

Proprietary Name: GlucoSmart Pro
Common Name: Diabetes Management Software
Product Code: DQO (Software, Medical Device)
Device Class: Class II
Regulation Number: 21 CFR 862.2100
Intended Use: Software intended to help diabetes patients track blood glucose levels and receive insulin dosing recommendations under healthcare provider supervision.

Step 3: 510(k) Submission

Predicate Device: MySugr Bundle (K171816)
Substantial Equivalence: Both devices provide diabetes management software with glucose tracking and insulin dosing support
510(k) Number: K241234 (assigned after clearance)
Clearance Date: March 15, 2024

Step 4: Annual Maintenance

Registration Renewal: Completed October 15, 2024
Device Listing Update: Updated software version from v1.0 to v1.1 on June 1, 2024
MDR Reports: No adverse events reported in first year of marketing

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Registration Timeline

Month 1: Completed establishment registration and initial device listing
Month 2-4: Prepared and submitted 510(k) application
Month 6: Received 510(k) clearance
Month 7: Launched device in US market
Month 12: Completed annual registration renewal

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Q&A