The problem
Most FDA questions are predictable.
When FDA puts a 510(k) on hold, the questions are rarely a surprise: an incomplete device description, a predicate comparison that does not hold up, performance testing that does not match the claims, thin software or cybersecurity documentation, or labelling that says more than the data supports. Each round of questions costs time the commercial plan never allowed for.
FDA now requires 510(k) submissions and De Novo requests to use its eSTAR electronic template. The template fixes the structure. It does not make the argument for you, and the argument is what the reviewer is reading.
We build the file around that argument first, and we keep pathway strategy, authoring and the answers to FDA questions in one team, so what you say in a response matches what you filed.
Talk to a specialist
Tell us the problem. A specialist replies, not a form robot.
What we do
What we deliver.
Pathway strategy
Classification, product code and predicate research, a 513(g) request where classification is unclear, and a clear recommendation between 510(k), De Novo and PMA.
What that means for you
- A pathway decision you can defend to your board
- Predicate and comparison risks named early
- A testing plan tied to the claims you want to make
Pre-Submissions
Pre-Submission packages under the FDA Q-Submission Program that ask the questions that matter, and preparation for the meeting itself.
What that means for you
- Specific questions, not open-ended ones
- Draft protocols FDA can comment on
- Minutes that record FDA feedback accurately
510(k) and De Novo packages
Authoring in eSTAR: device description, the substantial equivalence or benefit-risk argument, performance testing summaries, software and cybersecurity documentation, biocompatibility and labelling.
What that means for you
- Every section traced to its evidence
- Consistency checked across the whole file
- Prepared for FDA technical screening
Responses to FDA questions
Additional information requests answered inside the response window, with the testing or analysis each answer needs.
What that means for you
- A response plan agreed early in the window
- Answers that do not reopen settled sections
- Specialists staffed if new work is needed
Engagement write-ups appear here only once the client concerned has approved the wording in writing.We do not publish client names or outcomes without that approval.
How it runs
How a submission runs.
Pathway and gap review
Device, claims, predicates and existing evidence reviewed against the likely pathway.
Pre-Submission, where it helps
Questions to FDA on the points that could change the testing or the pathway.
Authoring and internal review
The file written in eSTAR and challenged section by section before it goes in.
Submission and responses
Submitted on your account, with responses to FDA questions handled by the same team.
Questions
Questions we get asked before the first call.
Do we need a Pre-Submission meeting?
Not always. It is worth it when the predicate is a stretch, the testing approach is unusual, or the device has software functions FDA is likely to probe. For a straightforward 510(k) with a close predicate it can cost more time than it saves, and we will say so.
Can you handle IVDs as well as devices?
Yes. IVD submissions carry their own expectations on analytical and clinical performance, and some need CLIA categorisation or a waiver, so we plan the studies and the submission together rather than one after the other.
Do you run the testing?
No. We define the testing the claims need, help you brief the laboratories and write the summaries. The testing itself is done by your teams or by accredited test houses.
Can you support FDA and EU routes at the same time?
Yes. Many device clients run FDA and EU MDR or IVDR routes in parallel, and keeping both in one team stops the two files contradicting each other.
FDA has already put our 510(k) on hold. Can you help?
Send us the request. We review it against the file, tell you which questions need new evidence and which need a better explanation, and help you answer inside the response window.
Related
Where to go next.
Post-market surveillance
Complaints, reportability and periodic reports once the device is on the market.
Read more ›Validation services
Software, process and test method validation behind the claims you file.
Read more ›Planning a device submission?
Tell us the device and the target date. A specialist replies with what the pathway really involves.