510(k) consulting.
FDA clearance is vital to your market success. Our consultants have over 15 years of experience making sure your 510(k) submission is accurate and complete.
Deficiencies cost months, not days.
A premarket notification is not a formality. Missing information and deficiencies in a 510(k) submission can delay a product launch by months — and for an overseas manufacturer entering the US market, that delay usually costs more than the submission itself.
Bio-Med USA has been on both sides of this process: we clear our own devices and we prepare submissions for other manufacturers. That means the advice comes from having run the process, not from having read the guidance.
Who this is for
- Overseas manufacturers entering the US market
- Class II devices requiring premarket notification
- Certain Class I and Class III devices seeking clearance
- Manufacturers who have received an AI request or a refuse-to-accept
- Companies needing establishment registration and device listing
How a submission runs.
Five stages from classification to listing. We work with you throughout — including the review period, which is where most first-time submitters lose time.
Device classification & predicate search
We establish the correct classification and identify a defensible predicate device — the single decision that most often determines whether a submission clears on the first pass.
Gap analysis against the guidance
Your existing technical file is assessed against the applicable FDA guidance and recognised consensus standards, and the gaps are listed before any writing starts.
Testing & documentation strategy
Biocompatibility, electrical safety, EMC, software and performance testing are scoped so nothing is commissioned twice and nothing is missing at submission.
Submission assembly & filing
The 510(k) is assembled in eSTAR format, reviewed for completeness, and filed. Missing information and deficiencies are what delay launches by months — this is where that is prevented.
Review support & FURLS registration
We work with you through the FDA's 90-day review period, respond to Additional Information requests, and complete establishment registration and device listing in FURLS.
What we do not claim.
No consultant can guarantee an FDA clearance, and any who does should be treated with suspicion. What preparation buys you is a submission without avoidable deficiencies — which is the difference between a 90-day review and a year of Additional Information cycles.
Discuss your submission.
Tell us the device, its intended use, and where you are in the process. We will tell you honestly what the path looks like.
Direct contact
- Phone
- +1-973-278-5222
- [email protected]
- Location
- New Jersey, USA