Your 510(k), built and
expert-reviewed in
8–12 weeks.
Complizen’s Submission Builder drafts every section. A senior FDA consultant reviews each one before you submit. Fixed fee, tiered by complexity. No surprises.
- Fixed fee per engagement
- Senior FDA consultant review
- 94% RTA pass rate
Kickoff & scope
Consultant call. Device confirmed, pathway locked, predicate shortlist approved.
AI builds the submission
All sections drafted by Submission Builder. You review as sections complete.
Expert review
Consultant reviews every section. Comments, revisions, sign-off loop.
Pre-flight & export
RTA pre-flight. eSTAR export. You upload to the FDA portal.
FDA submission live
We remain available through the review period and any AI request responses.
What you bring. What we build.
- Device description and intended use statement
- Predicate preferences (or we choose)
- Test reports and bench data (as available)
- Labeling and IFU drafts (or we draft)
- Biocompatibility data or equivalence rationale
- Software documentation (if applicable)
- Access to manufacturing/sterilization details
- Full classification, pathway, and predicate strategy
- All 22+ eSTAR sections, AI-drafted with citations
- Predicate comparison table and SE narrative
- Risk analysis seeded from MAUDE history
- Section-by-section expert review and sign-off
- RTA pre-flight check against current FDA criteria
- Complete eSTAR package, portal-ready
- AI request response support post-submission
Fixed fee. No hourly billing. No surprises.
Every engagement includes full AI drafting + senior consultant review. Complexity tiers reflect device type and submission scope — not billable hours.
Class II Standard
Traditional 510(k) for a straightforward Class II device with clear predicates and standard testing requirements.
- Full submission drafting
- 3 predicate options
- Senior consultant review
- RTA pre-flight check
- eSTAR export
- 30-day AI request support
Class II Complex
Devices with novel features, multiple predicates, or complex testing requirements (EMC, sterility, combination products).
- Everything in Standard
- Up to 5 predicates
- 2 expert review rounds
- Q-Sub strategy consult
- Testing plan guidance
- 60-day AI request support
- Priority turnaround
Software-Based / SaMD
Software as a Medical Device (SaMD) or device with significant software components requiring IEC 62304 documentation and cybersecurity review.
- Everything in Complex
- IEC 62304 documentation
- Cybersecurity pre-assessment
- Software lifecycle support
- FDA’s SaMD framework alignment
- 90-day AI request support
What if we need a Q-Sub meeting first?
We'll recommend a Q-Sub if your device is novel or the pathway is genuinely unclear. The Q-Sub prep and meeting management is included in the Complex and SaMD tiers, or available as an add-on to Standard.
What happens if FDA sends an AI request?
We respond. Every tier includes post-submission support for AI request responses — 30, 60, or 90 days depending on tier. We draft the response, the consultant reviews it, and you submit it. Same team, same workflow.
Do I need to have all my test data before starting?
No. We scope the submission first, then map what testing you still need. We can help you select labs, write test protocols, and integrate results as they arrive — without holding up the sections that don't depend on test data.
How does the expert review actually work?
Your consultant has a dedicated view in the Complizen workspace. They review sections as they're completed, leave inline comments and tracked changes, and flag items that need your input. You see every comment, approve every change, and sign off before anything goes to FDA.
Who are your FDA consultants?
Former CDRH reviewers, RA professionals with 10–25 years of direct 510(k) experience, and regulatory affairs PhDs. All consultants have submitted multiple 510(k)s independently before joining the Complizen network. We'll introduce you to yours before kickoff.