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I will prepare your complete fda 510k submission documentation
FDA Regulatory Affairs Specialist, Medical Device 510k Strategist
I am Funbi Festus, an FDA Regulatory Affairs & Quality Assurance Specialist helping MedTech innovators, hardware startups, and device manufacturers achieve seamless FDA clearance. With hands-on expert...
About this Gig
Navigating an FDA 510(k) clearance demands precision. Traditional regulatory consultancies charge $25,000+ for dossiers that drag on for months. I deliver institutional-grade, audit-ready 510(k) regulatory documentation formatted strictly for the FDAs mandatory eSTAR platform.
I construct a structured submission designed to minimize FDA Additional Information (AI) holds and avoid immediate RTA rejection.
Deliverables Covered in This Gig:
- FDA eSTAR Integration (nIVD / IVD formats)
- Executive 510(k) Summary & Administrative Documentation
- Comprehensive Device Description & Operational Principles
- Substantial Equivalence (SE) Detailed Comparison & Discussion
- Proposed Device Labeling, IFU, and Packaging Compliance
- Risk Management Summaries (ISO 14971) & Non-Clinical Test Protocols
- Guidance on FDA Form 3881 (Indications for Use)
I cover Class II hardware, disposables, electro-mechanical systems, and SaMD/AI-driven medical devices. Lets bypass bureaucratic friction and build a clean, defensible filing that gets you cleared.
Ready to move your device toward clearance? Contact me now or choose your package to begin.
Product stage:
Ideation
•
Prototype
Product type:
Physical Products
Industry:
Medical & pharmaceutical
Target country:
Worldwide
•
United Kingdom
•
United States
FAQ
Do you deliver the submission in the official FDA eSTAR format?
Yes. All documentation is prepared and structured according to the FDA Center for Devices and Radiological Health (CDRH) eSTAR template.
Does this gig include bench testing or lab testing?
No. Physical laboratory testing (biocompatibility, EMC, electrical safety) must be executed by your certified testing labs. I write and structure the validation summaries and test protocols.
What is the difference between RTA and an AI hold?
An RTA (Refuse-to-Accept) occurs within 15 days if mandatory components are missing. An AI (Additional Information) hold occurs during substantive review if scientific or technical explanations need expansion. My dossiers prevent both.
Can you handle Software as a Medical Device (SaMD)?
Yes. I cover SaMD documentation including software architecture, cybersecurity considerations, and level of documentation per FDA software guidance.
Will you act as our official US Agent?
This gig covers technical documentation drafting. Official US Agent services can be arranged separately if you are a foreign manufacturer.
What if the FDA has technical questions during their review?
Premium clients receive post-submission consultation to draft scientific, non-defensive responses to FDA reviewer inquiries.
