Pre-production brief
| Field | Answer |
|---|---|
| Reader | Founder, finance owner, or first RA/QA hire preparing a 510(k) budget. |
| Trigger | The board, investor, or leadership team is about to approve market-entry spend. |
| Blocked decision | Whether the budget covers only the FDA fee or the full evidence-preparation work. |
| Useful artifact | Cost-readiness brief with fee sources, quote checklist, timing assumptions, and owner questions. |
Reviewer workflow
- Record the current FDA fee page and fiscal year before presenting numbers.
- Separate standard FDA user fee, small-business timing, and quote-based testing costs.
- List lab, consultant, software, cybersecurity, biocompatibility, sterilization, usability, and internal-owner assumptions only when relevant to the device facts.
- Flag every line that needs a current quote or qualified reviewer decision.
Budget lines that need evidence
| Budget line | Evidence to gather |
|---|---|
| FDA user fee | Current FDA fee table and small-business status timing. |
| Testing | Device-specific guidance, standards, and current lab quotes. |
| Consultant work | Submission architecture, predicate review, evidence gap review, and response support scope. |
| Internal time | Named owner hours for evidence collection, review cycles, and decision meetings. |
What TrueMedDevice can prepare
TrueMedDevice can prepare the current fee-source ledger, quote-request checklist, assumption table, owner list, and open budget risks for review.
Source ledger
What it can tell you
FDA's current user-fee program context and fee references for medical-device submissions.
What it cannot decide
The total project cost, testing plan, consultant scope, or internal time required.
What it can tell you
Current FDA MDUFA fee tables by fiscal year and submission type.
What it cannot decide
Whether a 510(k) is required or sufficient for a specific device.
What it can tell you
FDA's small-business fee program context and timing considerations.
What it cannot decide
Whether the company will qualify or when a determination will be issued.
What it can tell you
FDA's electronic submission template context for device submissions.
What it cannot decide
Whether the submission content is complete or adequate.
Frequently asked questions
Is the FDA user fee the full 510(k) cost?
No. It is only one line. Testing, consulting, internal time, software, cybersecurity, standards, and response work may matter depending on device facts.
Can this page estimate my exact 510(k) budget?
No. It shows what to gather and how to separate source-backed fee references from quote-based and reviewer-dependent cost lines.
When should the small-business fee question be handled?
Early. The packet should include FDA small-business timing and owner responsibility before the submission timeline is locked.
Need a 510(k) budget-readiness packet before approval?
TrueMedDevice can organize fee sources, quote categories, owner assumptions, and open budget questions before you brief the board.
Reader feedback
Useful pages should feed the next topic choices. Leave a signal or a short comment.