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Foxwyn Global Assurance LLP
FDA / USFDA Regulatory Services

Foxwyn · Product-specific regulatory readiness

FDA / USFDA Regulatory Services

Food, cosmetics, medical devices and pharmaceuticals. Understand the applicable registration, listing and market pathway before preparing your application.

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Independent consultancy · Application support · Testing & inspection coordination

Registration is not product approval.

FDA and USFDA refer to the same US Food and Drug Administration. There is no universal FDA certificate for every business or product. The route depends on intended use, claims, product category and establishment activity. Indian state FDA and CDSCO permissions are separate from US requirements.

Establishment registration

Identifies an applicable facility or establishment. Requirements, exemptions, US-agent duties and renewal schedules vary by product sector.

Product listing & submission

Listing provides required product information; it does not itself mean approval. Devices, drugs and biologics may require separate premarket review.

Independent agency decision

Only FDA makes applicable clearance, authorisation or approval decisions. Foxwyn prepares and coordinates documentation; it does not issue FDA certificates or use the FDA logo as endorsement.

Scheme and organisation names identify reference pathways only. Original sector graphics are not government seals or certification marks. Foxwyn does not claim regulatory affiliation, certifier appointment or approval.

Explore the scope

Find the right service.

US Food and Drug Administration

US food facility registration

Facility registration and food-export compliance planning for applicable manufacturers, processors, packers and holders.

Who this is for

Applicable domestic and foreign food facilities serving the US market; check statutory exemptions. Foreign facilities require a US agent, and the facility’s accepted unique identifier must match its details.

Typical documents

  • Legal facility name, physical address and accepted UFI
  • Owner/operator and emergency contact details
  • US agent details for foreign facilities
  • Food categories, activities and facility records

Foxwyn’s support

  • Assess facility registration applicability and exemptions
  • Coordinate accepted identifier and US-agent information
  • Support registration, updates and biennial renewal
  • Review prior notice, labelling and importer FSVP responsibilities separately

Issuance & scope

Food facility registration is not FDA product approval or an FDA-issued certificate. FDA registration and FSVP importer responsibilities are separate obligations.

Enquire about this service Official scheme / provider reference

Document lists are indicative, not exhaustive. Scope, eligibility, fees, recognition and current requirements must be confirmed with the competent authority or independent certifier.

Registration, renewal & quality-system essentials

Food facility renewal

Applicable food facilities renew in each even-numbered year, from 1 October to 31 December. Foreign US-agent and accepted unique facility identifier details must be consistent with the registration.

Official guidance

Medical device quality systems

FDA’s Quality Management System Regulation (QMSR) became effective on 2 February 2026. It incorporates ISO 13485:2016 by reference with FDA-specific provisions; an ISO certificate alone does not prove all FDA obligations are met.

Official guidance

Different renewal schedules

Cosmetic facility registration generally renews biennially and product listings update annually; relevant exemptions apply. Drug/device establishments follow their applicable annual registration/listing schedules. Check sector-specific current guidance.

Official guidance

A clear engagement

From scope to submission readiness.

  1. 01

    Define the activity

    Product, location, operation, intended claims and target market.

  2. 02

    Map the right pathway

    Identify the authority, scheme, exemptions and current requirements.

  3. 03

    Build the evidence

    Prepare documents, records, samples and responsibility plans.

  4. 04

    Coordinate submission

    Support applications, independent inspections and query responses.

  5. 05

    Maintain readiness

    Track scope changes, applicable renewals and ongoing records.

Questions, answered.

Let’s define your next step.

Share your product, business activity, location and target market. We’ll review the relevant scope.

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