Medical Device
Establishment Registration
Medical Device Establishment Registration is the FDA process used by owners and operators of covered device establishments to identify their facility and regulated activities under 21 CFR Part 807. Registration is renewed annually, and most establishments that must register also have device-listing obligations. Registration and listing place information on file with FDA, but they do not mean that FDA has approved, cleared, certified, or endorsed the establishment or its devices.
FDA Registration Assistance handles the annual Medical Device Establishment Registration workflow for covered foreign and domestic device establishments — including FURLS/DRLM preparation, fee-payment coordination, registration submission, renewal support, and alignment with applicable device-listing and U.S. Agent requirements.
What Is Medical Device Establishment Registration & Who Must Register
Medical Device Establishment Registration is an annual FDA requirement for owners and operators of covered device establishments under 21 CFR Part 807. The exact registration, listing, and fee obligations depend on the establishment activity. Most establishments that must register also list the devices and activities performed there, while some categories — such as certain distributors — have different obligations or exemptions.
FDA Registration Assistance manages the establishment-registration workflow, annual renewal, FDA fee-payment coordination, and record updates. Device listing, U.S. Agent representation, QMSR support, labeling review, and premarket submissions are coordinated when applicable and can be scoped separately based on the device and establishment type.
- Annual registration applies to covered foreign and domestic device establishments
- Annual registration and listing review occurs October 1 – December 31
- FDA annual establishment fee is $11,423 for FY 2026 and $13,785 for FY 2027
- Most registering establishments also have device-listing obligations; some establishment types differ
- Foreign establishments subject to § 807.40 must maintain one U.S. Agent
Our Medical Device Establishment Registration Services
Everything medical device manufacturers need to register and remain compliant with the FDA — from initial establishment registration and device listing to annual renewal and ongoing FDA compliance support, handled end-to-end by experienced FDA regulatory specialists.
Establishment Registration Filing
We prepare and submit the establishment registration in FURLS/DRLM using the facility, owner/operator, official-correspondent, and activity information applicable to your establishment.
Device Listing Coordination
We determine whether your establishment must list devices and coordinate the required product-code, proprietary-name, premarket-submission, and activity information. Device-listing work can be scoped separately where applicable.
Annual Registration Renewal
We manage the annual establishment renewal process during FDA’s October 1 through December 31 window and review the registration information that must be kept current.
Ongoing Compliance Support
We support registration updates and related compliance coordination throughout the year, including U.S. Agent, device-listing, labeling, QMSR, and import issues when those requirements apply.
Trusted FDA Medical Device Registration Specialists
Helping foreign and domestic medical device manufacturers meet FDA registration requirements — ensuring compliant, timely establishment registration year after year.
How Our Medical Device Establishment Registration Service Works
A simple four-step process to get your medical device establishment registered and compliant with FDA requirements.
Submit Establishment Details
Provide the facility, owner/operator, establishment activity, U.S. Agent information if foreign, and the device information needed to determine your registration and listing obligations.
FDA Fee & Filing Prepared
We coordinate the FDA establishment-fee workflow, review the PIN/PCN requirements, and prepare the FURLS/DRLM registration data for submission.
Registration Submitted in DRLM
The completed registration is submitted electronically. FDA considers the establishment registered once the required payment identifiers have been applied and the FURLS confirmation is received.
Annual Renewal Managed
We support the annual October 1–December 31 renewal and coordinate registration, U.S. Agent, and device-listing updates that are required to keep the record current.
What a Registered Medical Device Establishment Must Do
Holding an active FDA establishment registration is not a one-time filing — it is an ongoing legal duty under 21 CFR Part 807. Each registered owner/operator must maintain, update, and prove these obligations year-round.
Submit Initial Registration on Time
Covered establishments generally submit initial registration within 30 days after beginning an activity subject to registration. Foreign establishments must register before exporting devices to the United States, and initial importers must register before importing.
Pay the Annual FDA User Fee
Unless a waiver applies, FDA requires the annual establishment registration fee to be paid first. FDA provides a PIN and, after payment processing, a PCN; both are then applied to the FURLS/DRLM registration.
Maintain Required Device Listings
Most establishments that must register also list the devices and activities performed at the establishment. Listing obligations vary by establishment type — for example, an initial importer registers but generally does not create the manufacturer’s device listing.
Renew Registration Each Fiscal Year
Annual registration information must be submitted between October 1 and December 31. Device-listing information must also be reviewed during that annual window and updated as required.
Keep Registration Information Current
Registration and listing information can be updated in FURLS/DRLM when facts change. Applicable changes should be submitted within the timeframes in Part 807 so the FDA record accurately reflects the establishment and its activities.
Maintain a U.S. Agent (Foreign Establishments)
A foreign establishment subject to 21 CFR § 807.40 must designate one U.S. Agent who resides or maintains a place of business in the United States. Changes to the U.S. Agent’s name, address, or phone number must be reported to FDA within 10 business days.
Meet QMSR / 21 CFR Part 820 Requirements When Applicable
The Quality Management System Regulation (QMSR) became effective February 2, 2026 and amended 21 CFR Part 820 by incorporating ISO 13485:2016. Device manufacturers subject to Part 820 must meet the applicable QMSR requirements and FDA’s updated inspection process.
Maintain Compliant Device Labeling
Registration does not replace device-labeling obligations. Each device must meet the applicable labeling, UDI, intended-use, and other requirements for its classification and marketing status.
Establishment Registration vs. Medical Device Listing
These two FDA requirements are filed together, use the same FURLS system, and are often spoken about interchangeably — but they are legally distinct obligations. Most companies need both.
| Establishment Registration | Medical Device Listing | |
|---|---|---|
| Who/What It Represents | The establishment, owner/operator, address, and regulated activities | The device(s) and the activities performed on those devices by establishments that have listing obligations |
| Required By | FD&C Act § 510 and 21 CFR Part 807 | FD&C Act § 510 and 21 CFR Part 807 |
| Primary Function | Tells FDA which covered establishments are involved in device production/distribution | Tells FDA which devices are associated with establishments and the relevant activity/product information |
| Timing | Initial registration when required; annual registration October 1–December 31 | Initial listing when required; listings reviewed annually October 1–December 31 and updated as applicable |
| Important Exception | Some establishment types register without creating device listings, including initial importers | Listing requirements depend on establishment activity; do not assume every registrant lists every device |
Registration and listing are related but legally distinct. Most establishments that must register also list devices, but the exact obligations depend on the establishment activity. FDA’s activity-specific registration-and-listing table should be used to determine what a manufacturer, contract manufacturer, sterilizer, specification developer, relabeler, repackager, foreign exporter, or initial importer must file.
Self-Filing Your Establishment Registration vs. Using FDA Registration Assistance
Filing your establishment registration yourself in FURLS is technically possible — but the failure modes are expensive. Here is an honest side-by-side.
| Self-Filing in FURLS | RecommendedFDA Registration Assistance | |
|---|---|---|
| Cost | No professional service fee; the FDA annual establishment registration user fee still applies unless a waiver is granted. | $849/year professional service; FDA annual establishment registration user fee paid separately. |
| Availability | Limited to your team's hours, time zone, and regulatory staffing capacity | Dedicated FDA regulatory specialists available year-round across global time zones |
| Domain-Specific Support | Your team interprets Part 807, establishment activities, product codes, listing rules, fee workflow, and U.S. Agent requirements. | FDA regulatory support from a firm serving clients since 2013, including registration workflow, activity review, fee coordination, and related compliance support. |
| Risk of Failure | Errors can delay registration or create mismatches between the FDA record, importer entry data, device listings, or U.S. Agent information. | Submission is reviewed for consistency before filing and the annual renewal workflow is tracked to reduce avoidable registration gaps. |
| Confirmation & Handling | Your team manages FURLS/DRLM confirmations and any subsequent registration or listing questions. | We provide the registration confirmation and available FDA identifiers, and support follow-up communications within the scope of our engagement. |
| Renewal & Update Tracking | Your team tracks the annual renewal and submits applicable registration, listing, and U.S. Agent updates. | Annual renewal and applicable mid-cycle registration/listing updates are coordinated as part of the service scope. |
The FDA government fee is the same whether you self-file or use a professional service. The value of professional assistance is in determining the correct establishment activity, coordinating payment and FURLS/DRLM steps, maintaining consistent records, and tracking the annual renewal and related updates.
Free FURLS Self-Filing vs. FDA Registration Assistance
FDA does not charge a separate "service" fee — anyone can create a FURLS account and self-file. Here is what that really costs in practice.
| Free FURLS Self-Filing | RecommendedFDA Registration Assistance | |
|---|---|---|
| Government Fee | FURLS/DRLM access itself does not add a separate filing-service charge, but the annual FDA establishment registration user fee applies unless a waiver is granted. | Our $849 professional service fee is separate from the FDA annual establishment registration user fee. |
| Pros | No professional service fee and direct control of your FDA account. | Professional handling of the establishment-registration workflow, annual renewal, fee coordination, and related Part 807 requirements. |
| Cons | Your team must determine the correct establishment activity, listing obligations, payment workflow, U.S. Agent requirements, and annual renewal timing. | Professional service fee; device listing, U.S. Agent, QMSR, labeling, and premarket work may require separate scope depending on your situation. |
| Best For | Organizations with experienced in-house medical-device regulatory staff who routinely manage FURLS/DRLM and Part 807. | Foreign manufacturers and growing device companies that want a managed annual registration workflow and coordinated regulatory support. |
Self-filing is permitted. FDA Registration Assistance is a private regulatory service and is not affiliated with FDA. Our service is designed for companies that prefer to outsource the registration workflow, annual renewal tracking, and coordination of related requirements rather than manage FURLS/DRLM internally.
Key Terms for FDA Medical Device Registration
Plain-English definitions of the regulatory terminology you'll encounter when registering and listing a medical device with the FDA.
The federal regulation governing medical-device establishment registration and device listing, including annual registration, listing information, foreign establishments, and U.S. Agent requirements.
FDA Unified Registration and Listing System — the FDA's online portal — and within it, the Device Registration and Listing Module used by device establishments to file registrations, listings, and amendments.
FDA Establishment Identifier. FDA uses FEI numbers across regulatory programs, but a new device registration can be completed even if a registration number has not yet been assigned. Do not treat FEI, owner/operator number, and registration number as interchangeable.
A unique identifier assigned by FDA to the parent owner or operator of one or more registered device establishments. One owner/operator can hold multiple establishment registrations.
An FDA identifier associated with an establishment registration when assigned. DRLM allows annual registration to be completed even if a registration number is still pending; the FURLS confirmation is the key evidence that the electronic registration was submitted.
The U.S.-based contact required for foreign device establishments subject to 21 CFR § 807.40. The agent assists FDA with communications, questions about devices, and inspection scheduling when requested.
The annual FDA establishment registration user fee. It is $11,423 for FY 2026 and $13,785 for FY 2027. It is paid to FDA separately from our professional service fee.
A Dun & Bradstreet identifier used in FDA facility identity records and validation workflows. It is not the payment confirmation for the annual device establishment fee; FDA uses the PIN and PCN from the Device Facility User Fee payment process for that purpose.
The separate filing under 21 CFR § 807.25 in which a registered establishment identifies each specific device it manufactures or distributes — by proprietary name, product code, and activity.
A three-letter FDA classification code assigned to each medical device product type. It determines the device's regulation, class (I/II/III), and premarket pathway.
A premarket submission demonstrating that a device is substantially equivalent to a legally marketed predicate device. Separate from — and usually in addition to — establishment registration for most Class II devices.
A statutory status applied to any device whose manufacturer's establishment is not registered or whose device is not properly listed. Misbranded devices may be detained at the U.S. border and subject to enforcement.
Common Causes of FDA Establishment Registration Failure
Most lapsed registrations, import refusals, and FDA warning letters trace back to the same small set of operational mistakes. Avoid these and your establishment stays continuously authorized to market devices in the U.S.
Missed October 1 – December 31 Renewal Window
Missing the annual registration window can leave a required establishment without a current registration for the new fiscal year. That can create misbranding and import-compliance problems until the registration is brought current.
Unpaid or Mis-Linked FDA User Fee
Registration is not complete until the annual FDA fee has been paid and the FDA-issued PIN and PCN are applied in FURLS/DRLM. Payment processing can take several days, so the fee workflow should be started early.
Missing or Outdated U.S. Agent
Foreign establishments subject to § 807.40 must designate one U.S. Agent and keep the agent’s contact information current. Changes to the agent’s name, address, or phone number must be reported within 10 business days.
Wrong Product Code or Establishment Activity
Incorrect establishment activities or device product codes can create inconsistent registration/listing records and complicate FDA review, import screening, and downstream compliance verification.
Inaccurate Establishment Address
The registration should identify the actual regulated establishment and its correct location. Mailbox-only or unrelated addresses can create identity and verification problems in FDA records.
Failure to Keep Registration Information Current
Part 807 requires current registration and listing information. Applicable updates should be submitted when facts change, and all registration/listing information should be reviewed during the annual cycle.
Inconsistent Facility / Owner-Operator Records
Legal-name, address, owner/operator, DUNS, and other facility-record inconsistencies can slow identity validation and create mismatches across FDA systems. The fee payment itself is confirmed using FDA’s PIN/PCN workflow.
Misleading FDA Approval Claims
Under 21 CFR § 807.39, establishment registration or assignment of a registration number does not denote FDA approval. Marketing that creates an impression of official FDA approval because a facility is registered can be misleading and can constitute misbranding.
Complete FDA Medical Device Registration Solutions
We offer a full range of FDA medical device registration and compliance services — from establishment registration and device listing to U.S. Agent services and annual renewals.
Medical Device Establishment Registration
Annual FDA establishment registration support for covered medical-device establishments under 21 CFR Part 807.
Medical Device Listing
Prepare and maintain required device listings, product codes, proprietary names, premarket references, and establishment activities when listing obligations apply.
Medical Device Labeling & Product Review
Ensure your medical device labels and product documentation meet FDA labeling requirements — reviewed by experienced FDA regulatory specialists.
Medical Device DUNS Request Assistance
Obtain or align a DUNS number used in FDA facility identity and validation workflows.
Medical Device U.S. Agent Services
Designate a U.S. Agent for a foreign medical-device establishment subject to 21 CFR § 807.40.
Medical Device Listing Certificate
Receive a professional verification certificate prepared from available FDA registration and device-listing records. It is not issued or approved by FDA.
QMS / cGMP Support
Build and maintain medical-device quality systems aligned with the FDA Quality Management System Regulation (QMSR), effective February 2, 2026, and ISO 13485:2016.
Medical Device Annual Establishment Renewal
Manage the annual October 1–December 31 FDA registration cycle and review the establishment record for required updates.
Import Alert & Device Detention Resolution
Support FDA medical-device import detentions and Import Alert matters with case-specific compliance and response strategy.
Laser Accession Report & Submission
Prepare the FDA Laser Product Report / Radiation Safety Product Report, coordinate CDRH submission, and follow the accession number for applicable laser products.
Frequently Asked Questions — Medical Device Establishment Registration
Find answers to the most common questions about FDA Medical Device Establishment Registration, annual renewal requirements, and how FDA Registration Assistance helps device companies stay compliant.
What is FDA Medical Device Establishment Registration?
FDA Medical Device Establishment Registration is the annual FDA filing for owners and operators of covered device establishments under 21 CFR Part 807. Registration identifies the establishment and its regulated activities. Most establishments that must register also have device-listing obligations. Registration does not mean FDA has approved or cleared the facility or its devices.
Who is required to register a medical device establishment?
FDA registration requirements depend on the establishment activity. Covered categories include many manufacturers, contract manufacturers, sterilizers, specification developers, repackagers/relabelers, reprocessors, foreign exporters, and initial importers. Some parties — such as domestic wholesale distributors that are not manufacturers or importers — are not required to register. FDA’s activity-specific registration table should be used for the final determination.
How often must a medical device establishment registration be renewed?
Required establishments submit annual registration information between October 1 and December 31. Device-listing information must also be reviewed during that annual period when listing obligations apply.
What is the FDA Medical Device Establishment Registration fee for FY 2026?
FDA’s annual establishment registration fee is $11,423 for FY 2026, which runs from October 1, 2025 through September 30, 2026. FDA has announced a $13,785 annual establishment registration fee for FY 2027 beginning October 1, 2026. The FDA government fee is paid separately from FDA Registration Assistance’s $849 annual professional service fee.
What regulation governs Medical Device Establishment Registration?
Medical Device Establishment Registration is governed principally by FD&C Act section 510 and 21 CFR Part 807. Part 807 addresses who must register and list, registration information, annual timing, foreign-establishment requirements, U.S. Agents, and related procedures.
Do foreign medical device manufacturers need to register with the FDA?
Foreign device establishments that perform activities requiring registration and offer devices for import into the United States must register with FDA. Foreign establishments subject to 21 CFR § 807.40 must also designate one U.S. Agent in the United States.
Is a U.S. Agent required for foreign medical device manufacturers?
Yes, for foreign establishments subject to 21 CFR § 807.40. The establishment must designate one U.S. Agent who resides or maintains a place of business in the United States. The agent assists FDA with communications, questions concerning the devices, and inspection scheduling when requested. Changes to the agent’s name, address, or phone number must be reported to FDA within 10 business days.
What is medical device listing and how does it relate to registration?
Establishment registration identifies the regulated facility; device listing identifies devices and activities associated with establishments that have listing obligations. Most registering establishments also list devices, but there are exceptions. For example, an initial importer generally registers and identifies manufacturers but does not create the manufacturer’s device listing.
What happens if I fail to register or renew my medical device establishment?
If an establishment that is required to register fails to do so, affected devices can be considered misbranded. FDA verifies registration and listing during import review, and products can be delayed, detained, or refused when required records are missing or do not match. Other enforcement consequences can also apply depending on the facts.
Does FDA Medical Device Establishment Registration require a 510(k) clearance?
Establishment registration and 510(k) clearance are separate requirements. Whether a device needs a 510(k), De Novo, PMA, or is exempt depends on its classification and regulation. When premarket authorization is required, the device generally should not be registered/listed for commercial distribution until the applicable authorization is in place.
What is the difference between a Class I, Class II, and Class III medical device?
FDA classifies devices into Class I, II, or III based on the level of regulatory control needed to provide reasonable assurance of safety and effectiveness. Many Class I devices are exempt from premarket notification, many Class II devices use the 510(k) pathway but some are exempt or use another pathway, and Class III devices generally require PMA unless another statutory pathway applies. Establishment registration is a separate obligation determined by establishment activity.
How does FDA Registration Assistance help with device establishment registration?
FDA Registration Assistance prepares the establishment-registration data, coordinates the FDA fee-payment workflow, submits the registration in FURLS/DRLM, provides the resulting confirmation and available identifiers, and supports annual renewal. Device listing, U.S. Agent, QMSR, labeling, and premarket work can be coordinated when applicable.
Can I update my establishment registration after submission?
Yes. FURLS/DRLM allows registration and listing information to be updated when facts change. The exact reporting deadline depends on the information being changed. U.S. Agent name, address, or phone changes for foreign establishments must be reported within 10 business days under § 807.40, and other Part 807 update requirements should be followed as applicable.
Is a small business fee waiver available for medical device registration?
FDA does not offer a routine reduced small-business rate for the annual establishment registration fee. For FY 2026 and FY 2027, FDA may grant a hardship waiver of the annual establishment fee — excluding initial registration — to certain businesses that qualify through the Small Business Determination program and meet FDA’s financial-hardship criteria.
How long does medical device establishment registration take?
The filing itself can often be completed quickly once the establishment information, FDA fee payment, PIN/PCN, and any required device information are ready. FDA notes that payment processing can take several days, so the overall timeline depends heavily on when the government fee is paid and whether the record requires clarification or correction.
How do I get started with FDA Medical Device Establishment Registration?
Provide the establishment name and location, owner/operator information, establishment activities, U.S. Agent information if foreign, and the device information needed to determine listing obligations. We review the scope, coordinate the FDA fee-payment steps, and prepare the FURLS/DRLM filing.
What does the $849 Medical Device Establishment Registration service fee include?
The $849 annual professional service covers preparation and handling of one establishment registration, FURLS/DRLM submission support, owner/operator and official-correspondent coordination, FDA fee-payment workflow guidance, registration confirmation, and annual renewal management. The FDA annual establishment registration user fee is separate. Device listing, U.S. Agent representation, QMSR work, labeling review, and premarket submissions may be separately scoped depending on the client’s needs.
Can my U.S. Agent or owner/operator be a friend, distributor, or unrelated third party?
A foreign establishment’s U.S. Agent may be an individual, firm, or other entity that meets 21 CFR § 807.40, including residing or maintaining a place of business in the United States and not being merely a mailbox or answering service. A distributor or other third party can serve if it can reliably perform the required role. The owner/operator is different: it is the entity directly responsible for the activities of the registered establishment and is not simply a contact role that can be assigned to an unrelated person.
What happens if my U.S. Agent doesn't respond to the FDA?
An unresponsive U.S. Agent can create a serious compliance and communication problem for a foreign establishment. Under § 807.40, the U.S. Agent must assist FDA with communications, questions about devices, and inspection scheduling when requested. FDA may contact the foreign establishment directly, but the establishment should promptly correct an outdated or ineffective agent designation rather than assume the registration remains compliant.
How do I change the U.S. Agent or owner/operator on an existing FDA establishment registration?
These are different changes. U.S. Agent changes are made through the foreign establishment’s registration record, and changes to the agent’s name, address, or phone number must be reported within 10 business days under § 807.40. Owner/operator and other registration changes are handled through the applicable FURLS/DRLM update or ownership-transfer workflow. We review the exact change before filing so the correct process is used.
Do I still need FDA Medical Device Establishment Registration if I only sell on Amazon, Shopify, Walmart, or eBay?
The sales channel does not determine whether registration is required. The question is whether your establishment performs an activity that requires registration under Part 807 and whether the product is a medical device intended for U.S. commercial distribution. A marketplace seller that is only a domestic distributor may have different obligations than the manufacturer, relabeler, specification developer, or initial importer.
Do I need to register if I only manufacture private-label or contract devices for another brand?
A contract manufacturer of finished devices is generally a registering and listing establishment under FDA’s activity table, even when another company owns the brand. Specification developers, relabelers, repackagers, sterilizers, and other parties can also have separate obligations. The correct registration depends on the activity performed at each establishment.
Can I use a residential address, virtual office, or P.O. Box as my registered establishment address?
The registration should identify the actual location of the regulated establishment. A residential address can be appropriate if the regulated activity genuinely occurs there. A P.O. box or mailbox-only/virtual address should not be used as a substitute for the actual establishment location. The address should be accurate and verifiable in FDA records.
Does FDA Establishment Registration mean my medical device is FDA-approved or FDA-cleared?
No. FDA explicitly states that establishment registration, assignment of a registration number, and device listing do not denote FDA approval, clearance, certification, or authorization. Under 21 CFR § 807.39, representations that create an impression of official FDA approval because an establishment is registered can be misleading and can constitute misbranding.
How can a buyer or customer verify that my Medical Device Establishment Registration is real and active?
FDA maintains a public Establishment Registration & Device Listing database. It can be searched using information such as company name, registration number, or owner/operator number. FDA states that the public database is updated weekly, usually on Monday, so it should not be described as a real-time database.
How is FDA Medical Device Establishment Registration different from FDA Food Facility Registration?
They are separate FDA programs under different statutory and regulatory frameworks. Medical-device establishment registration is under FD&C Act section 510 and 21 CFR Part 807 and is annual. Food-facility registration is under FD&C Act section 415 and 21 CFR Part 1, Subpart H and generally renews biennially in even-numbered years. Device establishments may also owe an annual FDA establishment fee, while FDA food-facility registration does not have the same annual device user fee.
If my facility makes both medical devices and other FDA-regulated products, do I need multiple FDA registrations?
Potentially, yes. FDA registration programs are product- and activity-specific. A facility that performs covered medical-device activities and also manufactures drugs, cosmetics, or food may have separate registration or listing obligations under each applicable regulatory program, subject to the exemptions and requirements of those programs.
Are any medical device establishments exempt from FDA registration or the user fee?
Yes. FDA’s activity-specific table identifies establishment types that do not register or do not pay the fee, and separate statutory exemptions can apply. In addition, FDA may grant a limited hardship waiver of the annual establishment fee — excluding initial registration — to certain qualified small businesses. Eligibility should be confirmed before relying on an exemption or waiver.
How quickly can FDA Registration Assistance restore my registration if it has lapsed or been canceled?
The timeline depends on why the registration is inactive and whether the current-year FDA fee has been paid, the FURLS/DRLM record can be reactivated or updated, and any separate import or enforcement issue exists. We can review the record promptly, but we do not guarantee a specific reinstatement time because FDA system processing and any related compliance issue are outside our control.
Do I need to re-register if I move my manufacturing facility to a new address?
A facility move can require changes to the establishment registration and associated FDA identifiers, and it may affect device listings tied to the location. The correct action depends on whether FDA treats the change as an update to the existing establishment or a new physical establishment. We review the move before filing rather than assuming a simple address amendment will always be sufficient.
Register Your Medical Device Establishment Today
Send us your establishment activity, facility location, and device information. We will review the registration scope, confirm the current FDA fee workflow, and prepare the appropriate FURLS/DRLM filing.
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