FDA Registration
FDA Registration And Listing
Register establishment and list devices with FDA establishing legal presence for US market access.
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.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.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
Special attention required for:
- Foreign establishments must designate a US Agent for FDA communications
- Software as Medical Device (SaMD) classification and listing requirements
- Combination products requiring coordination with other FDA centers
- Export-only manufacturers have different registration requirements
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.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.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.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.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.Example
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.FDA Registration and Listing Process Example
Step 1: Establishment Registration Company: DiabetesTracker Solutions LLCAddress: 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
Registration Timeline
Month 1: Completed establishment registration and initial device listingMonth 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
Q&A
When do I need to complete FDA registration and listing?
When do I need to complete FDA registration and listing?
You must complete establishment registration and device listing before marketing your medical device in the United States. Registration should be done early in your development process, but device listing can only be completed after you have FDA clearance or approval (for devices requiring premarket submission). Plan to complete registration at least 30 days before your planned market launch.
What is the difference between FDA registration and 510(k) clearance?
What is the difference between FDA registration and 510(k) clearance?
FDA registration establishes your company in the FDA database and lists your devices, while 510(k) clearance provides marketing authorization for specific devices. Registration is administrative and required for all establishments, while 510(k) clearance requires demonstrating substantial equivalence to a predicate device and is required for most Class II devices before marketing.
Do I need a US Agent if I'm a foreign company?
Do I need a US Agent if I'm a foreign company?
Yes, all foreign establishments must designate a US Agent who serves as the communication point with the FDA. The US Agent must be physically located in the United States, have authority to represent your company, and be available during normal business hours. The US Agent receives all FDA communications and can be contacted for inspections or regulatory matters.
How often do I need to renew my FDA registration?
How often do I need to renew my FDA registration?
You must renew your establishment registration annually between October 1 and December 31. The FDA sends renewal notices, but it’s your responsibility to complete the renewal. Failure to renew results in automatic cancellation of your registration, which prevents you from legally marketing devices until you re-register.
What happens if I make changes to my software after FDA clearance?
What happens if I make changes to my software after FDA clearance?
Minor software updates like bug fixes typically require an internal “letter to file” documenting the change and its impact. Major feature additions or changes affecting safety or effectiveness require FDA resubmission through a new 510(k) or PMA supplement. Develop a software change control strategy to avoid unnecessary retesting and resubmission requirements.
How do I determine the correct product code for my software device?
How do I determine the correct product code for my software device?
Use the FDA’s product classification database to find the appropriate product code based on your device’s intended use and technological characteristics. Common software codes include DQO (Software, Medical Device) for general software or specific codes like LLZ for physiological monitoring systems. When in doubt, consult with FDA through a pre-submission meeting to confirm the appropriate classification.