DUBBZ REGULATORY SERVICES LLC
21 CFR § 807.40 Statutory Representation & CDRH Advisory

U.S. FDA Regulatory Representation for Global Medical Device Manufacturers.

Dubbz Regulatory Services LLC serves as the official United States Agent and senior regulatory liaison for overseas Class I, Class II, Class III, and IVD medical device establishments entering the U.S. market.

Request Representation Agreement View Fee Structure

Transparent Representation & Advisory Scope

Direct senior regulatory oversight without hidden administrative tiers or automated mailbox delays.

21 CFR § 807.40 Mandate

Statutory FDA U.S. Agent Representation

$2,000 USD / establishment / year
  • Official U.S. Agent designation and rapid electronic verification within the FDA FURLS / DRLM portal.
  • 24-hour priority transmission of urgent FDA CDRH and Office of Regulatory Affairs (ORA) communications.
  • Liaison support for scheduling routine and directed FDA foreign establishment inspections.
  • Direct domestic contact point for FDA inquiries regarding imported devices offered for U.S. commercial distribution.
  • Annual FURLS establishment registration renewal verification window support (October–December).
Initiate U.S. Agent Appointment
Premarket, QMSR & Enforcement

Active Regulatory & Compliance Advisory

$225 USD / hour (or fixed-scope SOW)
  • Premarket regulatory strategy and submission authoring: 510(k), De Novo, PMA, and Q-Submission (Pre-Sub) meetings.
  • Quality Management System Regulation (QMSR / 21 CFR Part 820) and ISO 13485:2016 gap assessments and alignment.
  • Active FDA foreign inspection coordination, Form FDA 483 observation responses, and remediation strategy.
  • U.S. Customs and Border Protection (CBP) import detention resolution and FDA Import Alert petitioning.
  • Device classification assessments, product code verification, and UDI / GUDID compliance.
Inquire Regarding Consulting SOW

4-Step FURLS Appointment Workflow

Streamlined onboarding designed to clear FDA FURLS registration deadlines without friction.

STEP 01

Regulatory Intake

Submit your facility details, FEI number (if assigned), and target device classifications for rapid conflict and compliance screening.

STEP 02

MSA Execution

Execute our standardized FDA U.S. Agent Master Services Agreement defining statutory duties under 21 CFR § 807.40.

STEP 03

Retainer Settlement

Remit the annual $2,000 USD representation fee via domestic ACH or international wire transfer.

STEP 04

FURLS Confirmation

Enter Dubbz Regulatory Services LLC in your FDA FURLS DRLM account. We verify and confirm the FDA appointment request within 24 hours.