CENIT Consulting
FDA U.S. Agent for Medical Devices and Cosmetics only. Not for Food & Beverage or Food Facility Registration. Strategic compliance partner for MedTech and digital health.
CENIT Consulting serves as FDA U.S. Agent for foreign establishments in two sectors only: Medical Devices (including IVDs) and Cosmetics.
**Scope (per provider):**
- Medical devices and IVDs: U.S. Agent for foreign device manufacturers per 21 CFR Part 807
- Cosmetics: U.S. Agent for foreign cosmetic facilities under MoCRA
**Excluded:** Food & Beverage. CENIT does not provide Food Facility Registration or U.S. Agent services for food.
With offices in the EU and USA, CENIT offers regulatory and quality strategy for MedTech and digital health. Services include FDA registration and renewal, UDI/GUDID compliance, and Master File submission support for medical devices.
About
**Who they are**
CENIT Consulting is a strategic compliance partner for MedTech and digital health companies, specializing in FDA U.S. Agent services for medical devices and cosmetics.
**Expertise & scope**
* FDA U.S. Agent services for medical devices and IVDs, focusing on smooth and timely FDA communications for foreign establishments operating under 21 CFR § 807.
* Regulatory strategy and execution for EU MDR/IVDR and FDA pathways, including submission-ready documentation and realistic timelines.
* Quality Management System (QMS) establishment and optimization based on ISO 13485, integrating ISO 14971 risk management, IEC 62304 for software, and cybersecurity for SaMD and medical devices.
* PRRC (Person Responsible for Regulatory Compliance) services for EU MDR/IVDR, offering fast onboarding and ongoing compliance support.
* Support for medical devices including SaMD.
**Reputation / proof points**
* Experienced team focused on medical devices and IVDs.
* Fast onboarding for U.S. FDA Agent services.
CENIT Consulting is a strategic compliance partner for MedTech and digital health companies, specializing in FDA U.S. Agent services for medical devices and cosmetics.
**Expertise & scope**
* FDA U.S. Agent services for medical devices and IVDs, focusing on smooth and timely FDA communications for foreign establishments operating under 21 CFR § 807.
* Regulatory strategy and execution for EU MDR/IVDR and FDA pathways, including submission-ready documentation and realistic timelines.
* Quality Management System (QMS) establishment and optimization based on ISO 13485, integrating ISO 14971 risk management, IEC 62304 for software, and cybersecurity for SaMD and medical devices.
* PRRC (Person Responsible for Regulatory Compliance) services for EU MDR/IVDR, offering fast onboarding and ongoing compliance support.
* Support for medical devices including SaMD.
**Reputation / proof points**
* Experienced team focused on medical devices and IVDs.
* Fast onboarding for U.S. FDA Agent services.
Additional information
CENIT Consulting offers flexible engagement models for their U.S. FDA Agent services, allowing clients to select the level of involvement needed and upgrade their plan as compliance requirements evolve. They emphasize clear scope and fast onboarding, partnering with foreign establishments to ensure efficient communication with the FDA. Their services are specifically tailored for medical device and IVD manufacturers, aiming to streamline regulatory pathways and maintain compliance.
Key Highlights
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Provides U.S. FDA Agent services specifically for Medical Devices and IVDs.
Source
“We partner with medical device and IVD manufacturers (foreign establishments) operating under 21 CFR § 807.”
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Offers end-to-end regulatory strategy and execution for EU MDR/IVDR and FDA pathways.
Source
“End-to-end MDR/IVDR and FDA pathfinding with realistic timelines and submission roadmaps.”
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Specializes in ISO 13485-based Quality Management Systems for medical devices.
Source
“Build a lean, audit-ready QMS that accelerates EU MDR/IVDR and US FDA pathways.”
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Provides fast onboarding for U.S. FDA Agent services, with options to switch in 48 hours.
Source
“Switch to CENIT in 48 hours”
Certifications & Trust Signals
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Strategic compliance partner for MedTech and digital health.
Source
“Strategic compliance partner for MedTech and digital health.”
Buyer Snapshot
Best for
- Foreign medical device and IVD manufacturers requiring a U.S. FDA Agent.
- Companies seeking strategic regulatory compliance partners for MedTech and digital health.
How engagement typically works
- Flexible plan selection for U.S. FDA Agent services.
- Partnership approach for regulatory strategy and execution.
Typical deliverables
- FDA U.S. Agent representation.
- Submission-ready documentation.
- ISO 13485-based QMS.
- PRRC appointment and support.
Good to know
- Best when focused on medical devices and cosmetics; not for Food & Beverage.
Pricing
Model:
Onboarding + annual retainer
Public range:
Publicly listed: $329 - $1,350
Notes:
Based on publicly listed information; final fees depend on scope.
“$329; $725; $1,350; pricing,; $329”
HQ:
Houston, United States
Languages:
English
Timezones:
America/New_York, America/Chicago, America/Denver, America/Los_Angeles
Claim status:
Listed
Services & Capabilities
Best FDA US Agent Services | Compare & Get Quotes
Jurisdictions:
US
Countries:
US
Industries:
Medical devices, IVD, Cosmetics
Portfolio:
6-25
Flags:
fast_onboarding, ivd
Onboarding time:
2–7 days
Pricing model:
Onboarding + annual retainer
Starting from:
USD 329
Included services:
FDA communications handling, Inspection scheduling coordination, Registration support, Annual renewal reminders
Registration Support:
Yes
Inspection Support:
Yes
Product Type:
devices
Service Types:
US Agent Services, Inspection Support, FDA Submissions (510(k), PMA, IDE, etc.), Regulatory Consulting, Training/Education
Pricing:
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Response Time:
1 business day for FDA-labeled notices
Switch Time:
~48 hours
Specialization:
Devices & IVD only (foreign establishments)
Additional Services:
core: Official Correspondent (OC),Next-business-day SLA on all tickets,Annual registration/device-listing admin,1 consulting hour/year • plus: GUDID Regulatory Contact,eMDR Account-Owner setup,UDI bundle (≤ 10 DIs),+3 consulting hours
Target Market:
Foreign establishments only (non-U.S. device/IVD manufacturers)
Switch Discount:
15% off year-1 when switching from another agent
Scope:
Medical devices, IVD, and Cosmetics only. Not for Food & Beverage or Food Facility Registration.
Target Sectors:
Medical devices, IVD, Cosmetics
Excluded Sectors:
Food, Beverage, Food Facility Registration
Additional us_agent_fda Details
Included Services Detailed
Designation support and onboarding checklist for foreign establishment U.S. Agent setup, FDA communications receipt, acknowledgment, and routing to your designated contacts, Inspection scheduling support and operational readiness escalation (when applicable), Annual registration renewal reminders and administrative coordination
Excluded Services
Acting as importer of record, Commercial distribution management, Legal representation in enforcement actions
Onboarding Steps
Fast onboarding for U.S. FDA Agent services, with options to switch in 48 hours.
Coverage Details
U.S.-based agent coverage with defined business-hours availability and escalation path (seed summary).
Product Types
Medical Devices, IVDs, SaMD, Cosmetics
Registration Support
Yes, implied through U.S. FDA Agent services for foreign establishments.
Recall Support
Not explicitly stated.
Inspection Support
Not explicitly stated.
Emergency Contact24x7
Not explicitly stated.
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