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I will do fda medical device submission, 510k product code and predicate search
Jessica Palmer
About this gig
FDA MEDICAL DEVICE SUBMISSION: GET THE PRODUCT CODE, PATHWAY & PREDICATE RIGHT BEFORE YOU FILE
The wrong product code or predicate can cost you months and thousands in FDA fees. I fix that first.
WHAT YOU GET :
- FDA product code & regulation number
- Device class + pathway (510(k), De Novo or PMA)
- Predicate search & comparison table
- Special controls & recognised standards
- Testing roadmap (bench, biocompatibility, software)
- eSTAR gap analysis & RTA checklist
- Q-Sub questions to ask FDA
WHO IT'S FOR
Startups, overseas manufacturers & SaMD founders preparing a U.S. submission.
WHY ME :
Years in medical device regulatory affairs. Clear reports, no jargon, no guesswork.
Every report cites FDA's own databases and guidance, so you can verify every source.
HOW IT WORKS :
1. Send your device name & intended use
2. I research FDA databases
3. You receive a clear report & next steps
Regulatory research & support, not legal advice. FDA clearance is never guaranteed
Message me your device details for a free scope check, then order.
Get to know Jessica Palmer
Jessica Palmer
FDA 510k documentation support, organized, reviewed, ready
- FromUnited Kingdom
- Member sinceSep 2026
- Avg. response time1 hour
Languages
English
FDA 510(k) Documentation Support
I draft the documentation side of a 510(k): device descriptions structured the way reviewers expect, predicate device research with clear comparison tables, and section outlines your RA lead can actually use.
I provide structured, cited, review-ready documentation.
If you need a full regulatory strategy or submission filing, I will tell you honestly. If you need the documentation built, let's talk.
Message me with your device type and intended use.
FAQ
Do you guarantee FDA clearance?
FDA alone decides. I reduce risk by getting your product code, pathway and predicates right, so your submission starts on solid ground.
Do I need to share confidential data?
No. A device description and intended use are enough. Please don't send trade secrets. I'm happy to sign an NDA if you need to share more.
What if my device is Class III or has no predicate?
I'll tell you clearly. I assess PMA vs De Novo and explain what evidence is likely needed, so you know your true path before investing.
Do you file the submission for me?
My core service is the strategy and predicate report. For eSTAR compilation or filing help, message me first so we can confirm scope.
