Regulatory strategy · Local execution

FDA Regulatory Compliance &
U.S. Market Access

A clear, executable pathway from product classification, registration, and labeling review to U.S. representation, customs compliance, port-response support, and post-market maintenance.

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Food & Dietary Supplements
Cosmetics
Class I & Selected Class II Devices
Cross-border Logistics Solutions
Radiation-Emitting Products & Special Projects

Cross-border coordination

Shenzhen Project TeamClient management and documentation

U.S. Local EntityU.S. Agent and regulatory liaison

Vietnam CoordinationRegional project support

Core services

Start with the right pathway for your product or shipment

Each product category has different establishment roles, filing requirements, labeling rules, and post-market duties. We define the product and responsibility framework before filing begins.

Food & Dietary Supplements

Food facility registration and pre-import compliance

Support for foreign food facilities covering registration, U.S. representation, identity validation, Prior Notice, labeling, renewals, and regulatory communications.

Facility registration and renewalInitial registration, updates, biennial renewal, facility activities, and product categories.
U.S. Agent and FDA liaisonLocal contact support for FDA notices, questions, and facility-related communications.
DUNS and UFI validationAssistance with applications, corrections, and alignment of legal names, addresses, and facility identity.
Prior Notice filingReview of product, shipment, and importer information before food arrives in the United States.
Food labeling and claims reviewReview of Nutrition Facts, ingredients, allergens, net contents, and marketing claims.
Detention-risk and response supportAnalysis of Notices of Action, import alerts, sampling issues, and ITACS response documentation.

Registration data should align with the legal entity and DUNS record. FDA food facility registration does not constitute FDA approval.

Download intake form

U.S. Agent service

A U.S. Agent is an ongoing responsibility, not just an address

Foreign establishments need a dependable U.S. communication channel. YESFDA coordinates U.S. and China teams to translate official notices into clear evidence requirements, timelines, and execution steps while maintaining continuity of registration records.

U.S. entityLocal liaison and notice receipt

China executionFactory documentation coordination

Status maintenanceRenewals and change reminders

Event supportInquiry and import-response support

Official communication intake

Receive facility- or product-related FDA notices and identify the issue, deadline, and responsible party.

Bilingual execution support

Translate regulatory requests into documents, data, explanations, and internal actions a company can prepare.

Renewal and change management

Track annual or biennial renewal windows and maintain records when establishment information changes.

Regulatory event coordination

Coordinate response materials across the company, importer, and service providers without replacing legal advice or agency decisions.

Working method

Defined inputs, decisions, and deliverables at every step

We confirm the product and pathway before defining the evidence scope and execution plan. Status, open actions, and responsibility boundaries remain traceable.

Inquiry intake

Confirm the product, company role, target market, and current status.

Questionnaire and records

Collect intended use, labels, company information, and filing history.

Pathway and gap analysis

Assess classification, applicable rules, missing evidence, and key risks.

Regulatory execution

Complete the agreed filings, listings, liaison, and technical work.

Launch readiness

Review labels, import responsibilities, channel documents, and first-shipment items.

Lifecycle maintenance

Manage renewals, changes, notices, and post-market obligations.

Why YESFDA

Regulatory decisions and local execution stay connected

Our work is not centered on producing a certificate. It is centered on helping companies understand why a filing is needed, what evidence is required, who is responsible, and how the record will be maintained.

China-U.S. entity coordination

The U.S. team supports local liaison while the China team manages documentation and factory execution in Chinese.

Compliance informed by import scenarios

Our cross-border customs background helps identify data inconsistencies and arrival risks during the filing stage.

Defined project ownership

Each task identifies required inputs, process stages, client responsibilities, and deliverables.

Lifecycle coverage

Support continues from initial assessment through renewal, changes, label remediation, and regulatory events.

Client resources

Prepare the right information before the project begins

Not sure which form to use? Contact us

Food · PDF

Food Facility Registration Intake Form

Company, facility, U.S. Agent, activity, and food-category information required for registration.

Download form

Device · PDF

Medical Device Classification Questionnaire

Information used to assess product code, device class, and possible 510(k) requirements.

Download questionnaire

Device · PDF

Medical Device Registration Form

Establishment functions, listing, intended use, labeling, and U.S. importer information.

Download form

Process · PDF

Medical Device Registration Process

Project stages from inquiry intake and classification through registration and delivery.

View process

Key questions

Questions to resolve before a project starts

These answers explain common boundaries and do not replace a product- and fact-specific regulatory assessment.

Does FDA registration mean that a product is FDA approved?

No. Facility registration, establishment registration, and product listing are generally statutory filing requirements. They do not constitute FDA approval, certification, or endorsement. A separate assessment is required to determine whether a 510(k), PMA, or another premarket pathway applies.

Which foreign companies need a U.S. Agent?

U.S. contact requirements differ across food, medical devices, and cosmetics. The answer depends on the company's location, facility role, product category, and filing. A U.S. Agent is primarily a regulatory contact and is not automatically the importer, distributor, or legal representative.

Do the website services cover drugs and Class III medical devices?

Our standard focus is food, dietary supplements, cosmetics, Class I devices, and selected Class II devices. Drugs, Class III devices, PMA submissions, and complex clinical projects are not standard website offerings. We only determine whether to accept such work after a separate capability and partner review.

Can release be guaranteed after an FDA detention?

No. We can help analyze the notice, review filing and product records, organize evidence, and coordinate response materials. FDA, CBP, and other competent authorities retain final authority over inspections, detentions, releases, refusals, and related actions.

What information is needed for an initial assessment?

We typically need the legal company name and address, product name, intended use, principal ingredients or technical characteristics, label or packaging, target sales channel, and existing registration or import history. More complete information supports a more reliable classification and scope assessment.

Start an assessment

Start with your product information and receive a clear compliance pathway

Tell us your product category, company role, and target market. We will first confirm whether the matter is within scope, then identify the records needed and the next step.

info@yesfda.com US +1 840 244 9540 CN +86 158 1479 2283 Coordinated coverage across China and U.S. business hours

FDA Regulatory Compliance &
U.S. Market Access

Start with the right pathway for your product or shipment

Food facility registration and pre-import compliance

Registration, listing, and post-market obligations

From classification to annual registration maintenance

Cross-border logistics solutions

Ongoing compliance beyond the initial filing

A U.S. Agent is an ongoing responsibility, not just an address

Official communication intake

Bilingual execution support

Renewal and change management

Regulatory event coordination

Defined inputs, decisions, and deliverables at every step

Inquiry intake

Questionnaire and records

Pathway and gap analysis

Regulatory execution

Launch readiness

Lifecycle maintenance

Regulatory decisions and local execution stay connected

China-U.S. entity coordination

Compliance informed by import scenarios

Defined project ownership

Lifecycle coverage

Prepare the right information before the project begins

Food Facility Registration Intake Form

Medical Device Classification Questionnaire

Medical Device Registration Form

Medical Device Registration Process

Questions to resolve before a project starts

Start with your product information and receive a clear compliance pathway

FDA Regulatory Compliance &U.S. Market Access

Start with the right pathway for your product or shipment

Food facility registration and pre-import compliance

Registration, listing, and post-market obligations

From classification to annual registration maintenance

Cross-border logistics solutions

Ongoing compliance beyond the initial filing

A U.S. Agent is an ongoing responsibility, not just an address

Official communication intake

Bilingual execution support

Renewal and change management

Regulatory event coordination

Defined inputs, decisions, and deliverables at every step

Inquiry intake

Questionnaire and records

Pathway and gap analysis

Regulatory execution

Launch readiness

Lifecycle maintenance

Regulatory decisions and local execution stay connected

China-U.S. entity coordination

Compliance informed by import scenarios

Defined project ownership

Lifecycle coverage

Prepare the right information before the project begins

Food Facility Registration Intake Form

Medical Device Classification Questionnaire

Medical Device Registration Form

Medical Device Registration Process

Questions to resolve before a project starts

Start with your product information and receive a clear compliance pathway

FDA Regulatory Compliance &
U.S. Market Access