How to Register Your Medical Device Company with FDA: FURLS Setup, Fees, FDA Registration and Device Listing
- Beng Ee Lim
- 3 hours ago
- 18 min read
FDA establishment registration tells FDA where medical devices are made or processed (for example manufacturing, sterilization, relabeling, repacking) and carries an annual establishment registration fee of $11,423 for FY2026. Device listing tells FDA which devices are associated with that establishment, and when applicable it includes the relevant premarket reference such as a 510(k), De Novo, PMA, or an exemption status. Annual registration must be submitted each year between October 1 and December 31, and device listings must be reviewed and updated during the same window. For foreign manufacturers, establishment registration includes designating a U.S. Agent in FURLS, and foreign establishments must have the device listed before it may be imported into the United States. Registration and listing are separate from 510(k) clearance, but they interact, because your listing often references your premarket status.
What Is the Difference Between FDA Registration, Device Listing, and 510(k) Clearance?
Medical device teams often mix up three separate FDA requirements. Knowing the difference helps you avoid compliance gaps, shipment holds, and launch delays.
FDA Establishment Registration
What it is: Identifies the device establishment and the activities performed there (for example manufacturing, processing, sterilization, relabeling, repacking, specification development, depending on your role).
When required: Initial registration is due within 30 days after starting a regulated device operation under 21 CFR 807.20(a). Annual registration must be completed Oct 1 to Dec 31 each fiscal year.
Cost: $11,423 per establishment for FY2026.
Where it appears: Public Registration and Listing database (DRLM).
Authority: 21 CFR Part 807.
Device Listing
What it is: Identifies which devices are listed to that establishment, and what activities are performed on those devices.
When required: Listing information is submitted with initial registration, and device listings must be reviewed and updated annually Oct 1 to Dec 31.
Cost: No separate listing fee beyond the annual establishment registration fee.
Premarket link: If the device requires marketing authorization, the listing includes the FDA premarket submission number (for example 510(k), De Novo, PMA, PDP, HDE).
Product code: Listing typically includes the FDA product code used for classification and tracking.
510(k) Clearance
What it is: FDA’s determination that your device is substantially equivalent to a legally marketed predicate device.
When required: Many Class II and some Class I devices require a 510(k), unless exempt by regulation.
Cost: FY2026 user fee is $26,067 standard or $6,517 small business.
Outcome: A 510(k) number is assigned (a “K-number”).
Common confusion point
“I received 510(k) clearance. Can I ship now?”
Usually, not yet.
If you are required to register and list, you still need to:
Complete establishment registration and pay the annual fee.
List the device and, when applicable, link it to your premarket submission number.
For foreign manufacturers, ensure a U.S. Agent is designated as part of registration.
Practical tip: Use the public DRLM search to confirm your establishment and listings appear as expected, since it is updated regularly.
Who Must Register with FDA: Domestic and Foreign Manufacturers
21 CFR § 807.20 applies establishment registration and device listing requirements to the owner or operator of an establishment engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of a medical device intended for human use.
Domestic establishments required to register (common categories)
Manufacturers: make or assemble finished devices
Specification developers: create device specifications that a second party manufactures
Contract manufacturers and contract packagers
Contract sterilizers
Repackers and relabelers
Single-use device reprocessors
Initial importers: the first U.S. entity to import a device can be required to register, and for many devices their “listing” obligation is satisfied by identifying the manufacturer rather than listing the device themselves.
Foreign establishments required to register
Foreign establishments performing the same kinds of device activities must register and list under the foreign establishment provisions in 21 CFR § 807.40 when importing or offering for import into the U.S. Practical implication: for foreign manufacturers, registration and listing (and designating a U.S. Agent) needs to be in place before commercial import happens, otherwise shipments can be held.
Who is exempt from registration (common exemptions)
21 CFR § 807.65 lists exempt classes, including:
Wholesale distributors that do not manufacture, repackage, process, or relabel devices
Retail establishments (for example pharmacies and surgical supply outlets making final sale to the ultimate user)
Licensed practitioners who manufacture or alter devices solely for use in their practice
Research / teaching / analysis only activities, where devices are not introduced into commercial distribution
Certain dispensers/service providers whose primary responsibility is providing a service through use of previously manufactured devices
Decision tree: do I need to register?
Does your establishment manufacture, sterilize, repackage, relabel, reprocess, or develop specifications for a medical device intended for commercial distribution in the U.S.?
Yes → you likely must register (and often list), typically within 30 days after starting the regulated device activity.
No, R&D only with no commercial distribution → you may be exempt.
No, wholesale distribution only with no modifying activities → you are generally not subject to registration/listing.
Who Must List Devices: Registration vs Listing Requirements
In most cases, an establishment that must register must also list its devices. One common exception is the initial importer, which typically registers but does not list the device itself, because the foreign manufacturer’s establishment listing is the anchor in the system.
Must register and list
Manufacturers
Specification developers
Contract manufacturers and contract sterilizers
Repackers and relabelers
Single-use device reprocessors
Must register but typically does not list
Initial importers who did not develop device specifications and do not repackage or relabel the device. In practice, initial importers register and identify the foreign manufacturer, while the foreign manufacturer performs the device listing.
Initial importer definition
Under 21 CFR § 807.3(g), an initial importer is the first person in the U.S. who further markets a device from a foreign manufacturer to the person who makes the final sale or delivery to the ultimate user, and who does not repackage or change the container, wrapper, or labeling.
Example
Scenario: A Malaysian manufacturer ships orthopedic implants to a U.S. distributor that sells directly to hospitals without changing packaging or labeling.
Requirements:
Malaysian manufacturer: Must register and list the device (and, as a foreign establishment, designate a U.S. Agent).
U.S. distributor (initial importer): Must register (and identify the foreign manufacturer in the system), but typically does not list the device itself.
Hospital: Generally does not register or list unless it performs regulated manufacturing or reprocessing activities.
If the U.S. distributor repackages, relabels, or otherwise performs regulated device operations, it is no longer acting only as an initial importer and may have listing obligations associated with that role.
FDA Establishment Registration Process: Step-by-Step Guide
Step 1: Prepare your facility identifiers and legal entity details
Before you start DRLM, make sure your legal entity name and facility address are consistent across your records. FDA has contracted Dun & Bradstreet to verify certain facility details, including DUNS and addresses, so mismatches can slow you down.
Common pitfall: small differences in spelling or address formatting across systems can trigger verification issues.
Step 2: Pay the FDA establishment registration fee in DFUF
You generally must pay the annual establishment registration fee before you can complete registration and listing, unless FDA grants a waiver in limited situations.
FY2026 fee: $11,423 per establishment.
Pay through the Device Facility User Fee (DFUF) system. DFUF and FURLS/DRLM are separate systems, with separate accounts.
After you submit your DFUF order, FDA emails you a Payment Identification Number (PIN). After payment is processed, you receive a Payment Confirmation Number (PCN). Save both, you will use them during DRLM steps.
Annual registration window is October 1 to December 31.
Step 3: Access FURLS and enter the Device Registration and Listing Module (DRLM)
FURLS is the portal, DRLM is the module used for device establishment registration and listing. If you are unsure whether your company already has an account or who controls it, contact the CDRH Registration and Listing Help Desk.
Step 4: Complete registration and listing in DRLM
In DRLM, you will enter:
Establishment legal name and physical address
Establishment operations performed (for example manufacture, sterilize, relabel, repackage, specification developer)
Official correspondent contact information
U.S. Agent information if you are a foreign establishment
DFUF payment details (PIN/PCN as prompted by DRLM)
Avoid this mistake: selecting the wrong establishment operations. This is one of the easiest ways to create downstream corrections and import friction.
Step 5: Confirm assigned identifiers and public listing status
After your registration and listing are complete, FDA assigns establishment identifiers that can be viewed in the public Registration and Listing database once it refreshes. The public database is updated weekly, usually every Monday.
FDA Device Listing Process: Step-by-Step Guide
Device listing is completed in DRLM as part of your registration and listing obligations. Many teams do the listing during the same session as establishment registration, or immediately after, inside the same DRLM workflow.
Step 1: Confirm device classification and product code
Before you list, confirm:
Device class (I, II, or III)
FDA product code (the 3-letter code)
Regulation number (the 21 CFR classification regulation, where applicable)
Best places to confirm product code:
FDA Product Classification Database (most reliable for the code and regulation reference)
Your 510(k) clearance documentation (often includes product code, but still verify)
Your predicate device as a starting clue, but confirm the code in the database since edge cases exist
Teams often use Complizen at this step to pull likely product codes, the associated regulation and special controls, plus recent predicate patterns in one place, then they verify the final code in the FDA Product Classification Database before touching DRLM.
Common mistake: assuming the predicate’s product code automatically applies without confirming in the classification database.
Step 2: Gather your marketing authorization reference (if applicable)
In DRLM, when marketing authorization is required for the device, you will generally need to provide the relevant premarket reference, for example:
510(k) (K-number)
De Novo (DEN number)
PMA (P-number)
or indicate the device is exempt, where applicable.
Common mistake: trying to list a device as marketed in the U.S. without the required authorization reference when it is not exempt. For foreign establishments, import legality is tied to registration and required listing status.
Step 3: Complete the device listing in DRLM
Navigate: FURLS → DRLM → List a Medical Device.
Typical information you’ll enter includes:
Product code, class, regulation reference
Proprietary name(s) used to market the device
Common/usual name
Premarket reference (510(k)/DEN/PMA) or exemption status
Establishment operations performed for that device (for example manufacture, sterilize, relabel, repackage, specification developer)
Common mistake: listing only one proprietary name when the device is marketed under multiple brand names.
Step 4: Verify your listing is visible
After DRLM submission, verify your entry in DRLM and then confirm visibility in the public Registration and Listing database after it refreshes. The public database is updated weekly, typically every Monday.
FURLS System: Account Setup, Navigation, and Common Pitfalls
Creating Owner/Operator vs Official Correspondent Accounts
Owner/Operator Account:
Who typically creates it: Company owner or authorized manager
Purpose: Primary account used to manage establishment registration and listing records in DRLM
Typical responsibilities:
Managing establishment registration and device listing records in DRLM
Creating and maintaining account profile information that feeds DRLM records
Assigning/maintaining the official correspondent information as needed
Official Correspondent Account:
Who typically creates it: Created/managed through the organization’s FURLS account management workflow
Purpose: Day-to-day point of contact for registration/listing updates and FDA correspondence
Typical responsibilities:
Maintaining establishment registration and device listing information in DRLM
Receiving routine FDA communications tied to registration/listing records
Can the same person be both? Yes. Many small teams use one person as both owner/operator contact and official correspondent.
Never create duplicate FURLS accounts
A common mistake is creating a new FURLS account when one already exists for your organization. This can create confusion over which account controls the live DRLM records and can slow down corrections.
Before creating a new account:
Search internal email for prior “FURLS” or “FDA registration/listing” messages
Check with former employees or consultants who may have set it up
If you still cannot confirm ownership, contact the Registration & Listing help channels (for example via reglist@cdrh.fda.gov) to avoid duplicate-account confusion
If you forgot login credentials:
Use the FURLS “Forgot Password” recovery flow
If recovery fails, contact the CDRH Registration and Listing Help Desk
FURLS vs DFUF: two separate systems
A frequent point of confusion is that FURLS/DRLM and DFUF are different systems, with separate logins.
FURLS (FDA Unified Registration and Listing System):
Purpose: Access DRLM and manage establishment registration and device listing records
DFUF (Device Facility User Fee System):
Purpose: Pay the annual establishment registration fee
Workflow (typical):
Pay the annual fee in DFUF
Receive payment identifiers (PIN and PCN)
Enter the payment information in DRLM as prompted during registration/renewal steps
Annual registration renewal requirements and deadlines
Establishment registration is not one-and-done. Annual registration must be completed every fiscal year between October 1 and December 31, even if nothing changed. Listing information must also be reviewed and updated during the same window.
If you miss the December 31 deadline: the establishment can be placed into a failed to register or failed to list status and may not be considered active until FDA processes the required information, which can create avoidable business disruption for shipments and commercialization plans.
Renewal process (high level)
Even if nothing changed, you still must confirm accuracy during the annual window:
Pay the annual fee in DFUF and retain the payment identifiers
Log into FURLS and enter DRLM
Review establishment and listing information for accuracy
Update anything that changed
Submit and certify the annual registration
What to update after changes: the real 30-day rule
Beyond annual renewal, registration information updates must be made within 30 days of any change to the registration info described in §807.25(b).
Common triggers include:
Establishment name or address changes
Ownership changes
Contact information changes (including official correspondent and U.S. Agent details for foreign establishments)
Listing changes outside the annual window
Do not rely on a made-up “30-day listing rule.” The regulation says listing changes may be made at other times, such as when a device is introduced into commercial distribution, changed, or removed from distribution, and you must still review and confirm listings annually Oct 1–Dec 31.
Foreign Manufacturer Requirements: US Agent and Registration Timing
Foreign establishments have additional requirements beyond what many domestic manufacturers face, especially around the U.S. Agent and the rule that devices cannot be imported or offered for import unless the foreign establishment is registered and the device is listed.
US Agent Requirement for Foreign Manufacturers
Legal requirement: Every foreign establishment must designate a U.S. Agent as part of registration, and each foreign establishment designates only one U.S. Agent.
U.S. Agent responsibilities (what FDA expects):
Assist FDA in communications with the foreign establishment
Respond to questions about the foreign establishment’s devices that are imported or offered for import into the U.S.
Assist FDA in scheduling inspections of the foreign establishment
U.S. Agent does NOT:
Import devices or act as your distributor
Take responsibility for your regulatory compliance or device safety
Replace your regulatory consultant for submissions or responses to FDA review questions
U.S. Agent qualifications (practical requirements):
Must reside in, or maintain a place of business in, the United States
Must have a physical U.S. address, not a P.O. box
Can serve as U.S. Agent for multiple foreign establishments, as long as they can respond reliably to FDA communications
Can the U.S. Agent also be the Official Correspondent?
Yes. The regulation allows designating the U.S. Agent to act as the official correspondent.
Designating the U.S. Agent in FURLS/DRLM:
U.S. Agent information is submitted as part of the foreign establishment’s registration information (name, address, phone).
If the U.S. Agent’s name, address, or phone number changes, the foreign establishment or the U.S. Agent must report the change within 10 business days, not 30.
Cost of U.S. Agent services: Market pricing varies widely depending on service level and responsiveness. If you include a range, label it as “typical market range” rather than “FDA fee,” since FDA does not set this price.
Foreign Manufacturers Must Register BEFORE Importing
Critical rule: 21 CFR § 807.40(c) states that no device may be imported or offered for import into the U.S. unless it is the subject of a required device listing and is manufactured at a registered foreign establishment.
Plain English: you should not plan your first commercial shipment until:
Your foreign establishment registration is complete, and
Your device listing is in place in DRLM, including the applicable marketing authorization reference if the device requires one.
Practical timing for foreign manufacturers (sequence that avoids rework)
Scenario: Malaysian manufacturer wants to export an orthopedic implant to the U.S.
Step 1: Confirm product code and regulatory pathway (510(k) vs exempt vs other)
Teams often use Complizen during this step to rapidly map device description to likely product codes, see how similar predicates were classified, and keep the premarket reference aligned with the listing inputs, then they confirm the final code in FDA’s classification database before touching DRLM.
Step 2: Obtain the applicable marketing authorization if required (for example 510(k) clearance)
Step 3: Register the foreign manufacturing facility in DRLM and designate the U.S. Agent
Step 4: List the device in DRLM with the correct product code and the applicable marketing authorization reference (or exemption status, if truly exempt)
Step 5: Plan first shipment only after registration/listing is in place, because import eligibility is tied to the 807.40(c) requirement.
What happens if you ship before registering and listing
If a foreign establishment ships devices before it meets the 807.40(c) requirement, the shipment can be held until the registration/listing issue is resolved, which creates avoidable cost and timeline disruption.
FDA Establishment Registration Fees and Small Business Waivers (FY2026)
Standard Registration Fee: $11,423 (FY2026)
The Medical Device User Fee Amendments (MDUFA) authorize FDA to collect annual establishment registration fees.
FY2026 fee: $11,423 per establishment
FY2025 fee: $9,280 per establishment
Increase: 23.1% year-over-year (FY2025 → FY2026)
Historical fee progression:
FY2024: $7,653
FY2025: $9,280
FY2026: $11,423
Trend: Fees change annually and can move materially year to year, so budget conservatively for increases.
Fee is per establishment, not per device
1 facility manufacturing 50 devices = $11,423 total
3 facilities manufacturing 10 devices each = $34,269 total ($11,423 × 3)
When the fee is due
Initial registration: fee must be paid as part of the registration process
Annual renewal: October 1 to December 31 each year
Small Business Waiver: $1 Million Gross Receipts or Sales Threshold
Starting in FY2026, FDA may grant a waiver of the annual establishment registration fee (excluding the initial registration) for certain small businesses that meet the statutory criteria and demonstrate financial hardship.
Key point: FDA does not offer a reduced registration fee. It is either paid in full or, if eligible, waived.
Eligibility criteria (all must be met)
Gross receipts or sales: business and affiliates have $1 million or less in the most recent tax year
Financial hardship: you must demonstrate that paying the fee represents financial hardship, bankruptcy is a commonly cited example
Prior-year payment: you have proof that you paid the registration fee in a prior fiscal year
Important limitation: This waiver excludes initial registration, it is designed for annual renewals.
Application process (what to fix in your draft)
Your “submit by July 31” line is not consistent with FDA’s published acceptance windows.
FDA accepts Small Business Requests beginning August 1 prior to the next fiscal year, and for FY2026 status, requests are accepted from August 1, 2025 through September 30, 2026.
For the registration fee waiver, FDA accepts SBRs through October 31 for actively registered firms.
Use Form FDA 3602N and submit through the CDRH Portal as required.
Small Business Fee Reductions for 510(k) Submissions
This is separate from the establishment registration fee waiver.
Small business threshold for reduced MDUFA submission fees: business and affiliates have $100 million or less in gross receipts or sales.
FY2026 510(k) fees:
Standard: $26,067
Small business: $6,517 (25% of standard, meaning a 75% reduction)
What Happens After Registration: Public Database, Inspections, and Reporting
Establishment registration has downstream operational implications, including public visibility, inspection readiness expectations, and reporting obligations that apply based on your regulatory role.
Public Database Listing
After you submit registration and listing information, your establishment and listing records become searchable in FDA’s public Registration and Listing database after it refreshes. The database is updated weekly, usually every Monday, and there may be a delay before changes appear publicly.
Database: Establishment Registration & Device Listing search portal.
Publicly releasable information typically includes:
Establishment name and address
Registration and listing information that is releasable under FOIA
Listing-related identifiers such as product codes and device listing entries
Not typically displayed publicly:
Certain internal contact details used for correspondence and administration
FDA Inspection Eligibility
Registered device establishments should operate as if they are inspection-ready under FDA’s Quality Management System Regulation (QMSR) in 21 CFR Part 820. Inspections are risk-based and can occur at any time based on FDA priorities and signals.
Inspection scope commonly covers quality system elements such as:
Design controls (where applicable)
Supplier controls
Production and process controls
Corrective and preventive action (CAPA)
Complaint handling
Labeling controls
Device master record and device history record controls (as applicable under Part 820)
U.S. Agent role (foreign establishments): FDA may contact and coordinate inspection scheduling and communications through the U.S. Agent.
Medical Device Reporting (MDR) Obligations
MDR requirements apply under 21 CFR Part 803 based on whether you are a manufacturer, importer, or device user facility, not simply because you registered. If you are a manufacturer or importer, you generally have mandatory reporting obligations for certain device-related events.
For manufacturers, reportable events generally include:
Device-related deaths
Serious injuries
Certain malfunctions that would be likely to cause or contribute to a death or serious injury if they were to recur
Reporting timeline (manufacturer baseline):
Many MDRs are due within 30 calendar days after you become aware of a reportable event
Certain situations require 5-day reports under Part 803
How to report:
Typically through eMDR, using the appropriate FDA reporting mechanism and forms (Form 3500A is commonly used for mandatory reporting).
Failure to comply with MDR can lead to FDA enforcement actions, so teams usually formalize MDR workflows as part of post-market readiness, not as an afterthought.
How to Verify Your Registration Status
To confirm your registration and listing are visible:
Use the public Registration & Listing search portal
Search by company name or other identifiers
Remember the database updates weekly, so recent changes may not appear immediately.
If status indicates you are not current, common causes include missing annual renewal steps or incomplete fee/payment steps during the annual window.
Common Registration and Listing Mistakes: What to Avoid
These are common errors teams run into when using FURLS/DRLM for establishment registration and device listing.
Mistake 1: Creating Duplicate FURLS Account
The problem:
You already have a FURLS account from a prior year but cannot locate credentials, so you create a new account.
Consequences:
Confusion over which account controls the active DRLM records
Slower troubleshooting and corrections, especially during annual renewal windows
Fix:
Check internally for an existing account before creating a new one
Use password recovery rather than creating duplicates
If you still cannot confirm ownership, contact reglist@cdrh.fda.gov
Mistake 2: Listing a device without the required marketing authorization reference
The problem:
You try to complete device listing for a non-exempt device without the applicable marketing authorization reference (for example 510(k), De Novo, or PMA).
Consequences:
DRLM may not accept the listing as complete, or you will have to return and update the listing later once the authorization reference exists
Fix:
For exempt devices, list using the appropriate exemption status
For devices requiring marketing authorization, ensure your DRLM entry includes the correct authorization reference when prompted
A practical way to reduce this failure mode is validating product code + authorization reference alignment before you touch DRLM. Teams use Complizen here to cross-check product code assumptions against similar devices and predicates, which reduces rework later.
Mistake 3: Missing the annual renewal deadline (December 31)
The problem:
You miss the renewal window and attempt to renew after December 31.
Consequences:
Establishment can fall into “failed to register” or “failed to list” status until annual registration is completed, which can create commercialization and shipment disruption.
Fix:
Set internal reminders for October 1
Pay and submit early, don’t wait until late December
Mistake 4: Facility details don’t match verification records
The problem:
Company name or address details entered in DRLM do not match the supporting records used for verification.
Consequences:
Verification issues can delay completion and require corrections
Fix:
Confirm legal entity name and facility address formatting before you start
Use consistent spelling and formatting across systems
Mistake 5: Incomplete proprietary name entries
The problem:
You list only one proprietary name even though the device is marketed under multiple brand names.
Consequences:
Partners and customers may not be able to easily verify the device under the expected marketed name in public listings
Fix:
List the proprietary names used to market the device
Update listings when marketed naming changes, and confirm accuracy during the annual renewal window.
Mistake 6: Forgetting to designate a U.S. Agent (foreign manufacturers)
The problem:
A foreign establishment tries to complete registration without a U.S. Agent designation.
Consequences:
Registration cannot be completed correctly for a foreign establishment without a U.S. Agent designation.
Fix:
Identify a U.S. Agent before you begin foreign establishment registration
Ensure U.S. Agent details are complete and current
Mistake 7: Mixing up FURLS/DRLM vs DFUF credentials
The problem:
You attempt to log into DFUF using FURLS credentials (or vice versa).
Consequences:
Payment workflow stalls because DFUF and FURLS/DRLM are separate systems
Fix:
DFUF is for fee payment
FURLS/DRLM is for registration and listing entries
Typical workflow: pay DFUF, retain PIN and PCN, enter payment information in DRLM as prompted.
Mistake 8: Not updating registration after facility moves or operational changes
The problem:
You move facilities or change establishment activities but do not update registration details.
Consequences:
Registration information becomes inaccurate
Registration updates are required within 30 days of changes to registration information.
Fix:
Update registration within 30 days after address or activity changes
Confirm physical and mailing addresses are correct
The Fastest Path to Market
Frequently Asked Questions:
Do I need to register before submitting a 510(k)?
No. You can submit a 510(k) before you complete establishment registration, but you must complete any required registration and listing steps before you commercially distribute a device in the U.S.
Can I market my device after registration but before 510(k) clearance?
Not if your device requires a 510(k). Establishment registration and listing do not replace premarket authorization requirements. For exempt devices, you may be able to register and list without a 510(k).
What’s the difference between FEI and a device listing number?
FEI identifies the facility, it is typically a 10-digit FDA establishment identifier used to track the site. A listing number links a listed device to the establishment and the applicable product code and marketing authorization reference when required.
Do contract manufacturers and contract sterilizers need their own registration?
Yes. Each establishment performing covered activities, like manufacturing or sterilization, registers separately and pays the annual establishment registration fee for that fiscal year.
Can I manage multiple facilities under one FURLS account?
Yes. One Owner/Operator account can manage multiple establishments, but each establishment has its own registration and annual fee.
How do I confirm my registration and listing are live?
Use DRLM to confirm your submission status, and use the public Registration and Listing search to verify your record appears after the weekly database refresh.
When do foreign manufacturers need a U.S. Agent?
Always. Foreign establishments must designate a U.S. Agent as part of registration, and changes to U.S. Agent details must be reported within 10 business days.
What happens if I miss the Oct 1 to Dec 31 annual renewal window?
You can fall out of current registration status until you complete annual registration and listing review. That can disrupt imports and commercialization, so plan renewal early in the window.