You will get MEDICAL DEVICE: US FDA FACILITY REGISTRATION
Project details
Who must register with the FDA?
According to the U.S. FDA, all medical device establishments that develop, manufacture, pack, assemble, label, export, or import medical devices into the US must register with the agency and pay an annual user fee of 9,280 USD (2025). Registered medical device establishments must also list all their medical devices individually through the Device Listing process before starting commercial distribution in the U.S. market. Medical devices cannot be cleared to enter the US market without a valid device listing number.
What is FDA device classification?
Companies must classify medical devices for proper listing as part of device establishment registration. The FDA categorizes medical devices into three classes: Class I, Class II, and Class III, based on the associated risks. The FDA Device Classification Database contains device names, technical descriptions, and related product codes that identify a device’s generic category for the FDA.
According to the U.S. FDA, all medical device establishments that develop, manufacture, pack, assemble, label, export, or import medical devices into the US must register with the agency and pay an annual user fee of 9,280 USD (2025). Registered medical device establishments must also list all their medical devices individually through the Device Listing process before starting commercial distribution in the U.S. market. Medical devices cannot be cleared to enter the US market without a valid device listing number.
What is FDA device classification?
Companies must classify medical devices for proper listing as part of device establishment registration. The FDA categorizes medical devices into three classes: Class I, Class II, and Class III, based on the associated risks. The FDA Device Classification Database contains device names, technical descriptions, and related product codes that identify a device’s generic category for the FDA.
Project Type
Business Consulting, LegalWhat's included
| Service Tiers |
Starter
$150
|
Standard
$400
|
Advanced
$450
|
|---|---|---|---|
| Delivery Time | 2 days | 6 days | 6 days |
Number of Revisions | 1 | 1 | 1 |
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JE
Joseph E.
May 27, 2026
Program Relaunch Compliance Review
Great work, does what is asked
MC
Matt C.
May 22, 2026
FDA Establishment Registration and Device Listing - Review and Submission (Class I Medical Device)
Cheryl is precise, exacting, punctual and somehow makes sense out of a convoluted government bureaucratic process.
She is fantastic to work with and we are already discussing our next project together.
Highly recommended - 💯
Thank you, Cheryl!
She is fantastic to work with and we are already discussing our next project together.
Highly recommended - 💯
Thank you, Cheryl!
YL
Yoonique L.
Apr 30, 2026
FDA Packaging Compliance Review – Baby Snack (Pre-Final Design Stage)
Cheryl did exactly what we hoped for within the time frame specified.
JP
Jaee P.
Mar 19, 2026
Report on certificates, lab tests and documents requirements for import.
Cheryl is very thorough with her reviews. We will be hiring her again and highly recommend her for any FDA compliance needs you may have.
MV
Mike V.
Aug 30, 2025
Import Alert Advice
Great experience working with Cheryl. Very knowledgeable and excellent communication skills. She completed the project in less time than promised and went above and beyond.
About Cheryl
FDA Regulatory Consultant- 510K/FTC,/Label Review/ Registrations/FIFRA
94%
Job Success
Manteca, United States - 6:38 pm local time
RAC-Devices Certified Regulatory Affairs Professional (RAPS) with 12+ years of experience supporting FDA-regulated products across medical devices, cosmetics, food, dietary supplements, and EPA-regulated products (FIFRA).
ISO 13485:2016 Lead Auditor Certified with strong expertise in Quality Management Systems, audit readiness, and regulatory compliance.
Fixed-fee and milestone-based projects available for clarity and faster execution.
What I Can Help You With
FDA & Global Regulatory Strategy
• 510(k) submissions (end-to-end support)
• FDA classification & regulatory pathway (incl. Q-Sub)
• Health Canada MDR, EU MDR / PPE, UKCA
• Multi-country product registrations (US, Canada, EU, UK, LATAM, Russia)
ISO 13485 & Quality Systems
• ISO 13485 implementation & gap analysis
• Internal audits & audit readiness (mock audits)
• SOP development & QMS structuring
• CAPA, nonconformities, and risk-based compliance
EPA / FIFRA & Pesticide Compliance
• State registrations
• Label review for EPA compliance
• Confidential Statement of Formula (CSF) review
• Multi-state strategy
Labeling & Claims Compliance
• FDA labeling (devices, cosmetics, food, supplements)
• Claims risk assessment (FDA / FTC / Amazon compliance)
• Structure/function vs drug claim evaluation
• UDI compliance (GS1, GUDID submission)
• MoCRA registration & cosmetic compliance
Technical & Regulatory Documentation
• EU MDR / PPE technical files
• Design and regulatory documentation
• Gap analysis & compliance roadmap
Specialized Regulatory Support
• FDA Import Alerts & petition support
• CA Prop 65 risk assessment
• REACH / SVHC compliance
• SDS / MSDS development
• UL / NFPA certification support
Proven Impact
• Managed 20+ FDA 510(k) submissions
• Reduced submission timelines from 9–12 months to 4–8 months
• Saved clients $500K+ in regulatory/testing costs
• Led regulatory projects across 10+ countries
Why Clients Work With Me
• RAC-certified + ISO 13485 Lead Auditor
• Strong regulatory + business mindset
• Clear communication and fast turnaround
• Practical, actionable guidance (not overly theoretical)
If you need support, feel free to reach out. I’m happy to review your project and provide clear next steps.
Steps for completing your project
After purchasing the project, send requirements so Cheryl can start the project.
Delivery time starts when Cheryl receives requirements from you.
Cheryl works on your project following the steps below.
Revisions may occur after the delivery date.
Gather all the required information from the client.