What is Establishment Registration?
FDA Establishment Registration is a mandatory annual process in which medical device companies notify the FDA about their business operations. Any organization involved in the manufacture, preparation, propagation, compounding, assembly, processing, sterilization, or distribution of medical devices intended for the US market must register.
Registration is completed electronically through the FDA Unified Registration and Listing System (FURLS).
Important: FDA establishment registration does not constitute FDA approval or clearance. It is a regulatory requirement that allows the FDA to identify medical device facilities, conduct inspections, and perform post-market oversight.
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Medical Device Listing
As part of the medical device listing mandate, organizations must furnish information about the devices they manufacture. This includes providing a premarket submission number, such as 510(k), PMA (Premarket Approval), HDE (Humanitarian Device Exemption), etc., to the FDA if the device necessitates premarket procedures.
What Is Medical Device Listing?
Medical Device Listing is the process of submitting information about each medical device marketed in the US under a registered establishment.
During device listing, organizations must provide details such as:
- Device name and FDA classification
- Regulatory pathway (FDA 510(k), PMA, HDE, or Exempt)
- Premarket submission reference number (if applicable)
- Proprietary device names and activities performed
Relationship Between Device Listing and FDA 510(k)
If a medical device requires FDA 510(k) clearance, the 510(k) number must be included during device listing once clearance has been granted. Device listing links the cleared product to the registered manufacturing or distribution facility and supports FDA post-market surveillance activities.
Who Needs to Register With the FDA?
FDA establishment registration is required for:
- Medical device manufacturers (US and foreign)
- Contract manufacturers
- Specification developers
- Sterilization service providers
- Repackers and relabelers
- Initial importers (registration required)
What Are the Steps Involved in the Medical Device Establishment Registration Process?
- Create/log in to the Facility User Fee Account with the US FDA
- Verify/update Company Details and Generate the Payment Identification Number (PIN)
- Pay the 2024 Annual Registration User Fee Of $7,653 Electronically Through the Device Facility User Fee (DFUF) Website.
- Registration and Listing Data is Entered Via the US FDA’s Unified Registration and Listing (FURLS)/the Device Registration and Listing Module (DRLM).
- After the Registration Process is Complete, the US FDA Assigns an FDA Establishment Identifier (FEI) and Issues a Certificate Via the FDA Listing Inc.
Also, read about A Guide to FDA eSTAR Submission Template
How FDA Establishment Registration Supports FDA 510(k) Submission?
FDA establishment registration is a foundational requirement for companies pursuing FDA 510(k) clearance:
- Required before commercial distribution in the US
- FEI is used during FDA inspections and audits
- Device listing links cleared products to registered facilities
- Supports FDA compliance monitoring and post-market surveillance
For companies preparing an FDA 510(k) submission, establishment registration and listing must align with:
- Device classification
- Intended use and indications
- Manufacturing site information
- Quality System Regulation (21 CFR Part 820) requirements
Common Mistakes to Avoid
- Missing the annual registration renewal window
- Incorrect medical device classification
- Listing devices before receiving FDA 510(k) clearance
- Inconsistent company information across FDA systems
- Not appointing a US Agent for foreign manufacturers
These issues can delay FDA 510(k) clearance, disrupt market access, or lead to regulatory action.
How Operon Strategist Helps With FDA Establishment Registration & FDA 510(k)?
Operon Strategist provides end-to-end FDA regulatory support for medical device companies entering or expanding in the US market.
Our Services Include:
- FDA Establishment Registration & Medical Device Listing
- FDA 510(k) regulatory strategy and submission support
- FDA eSTAR submission assistance
- Medical device classification and pathway assessment
- Quality Management System (QMS) alignment with FDA requirements
- Post-market compliance and FDA audit support
- US Agent services for foreign manufacturers
By partnering with our regulatory experts, medical device companies reduce compliance risks, avoid regulatory delays, and accelerate US market entry.
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FAQ'S
Yes. All medical device manufacturers must register their establishment annually before marketing a device cleared under FDA 510(k).
No. Establishment registration is not approval. FDA 510(k) clearance or PMA approval is required separately.
Yes. Foreign manufacturers must appoint a US Agent as part of FDA establishment registration.
After receiving FDA 510(k) clearance or if the device qualifies for exemption.
