What a startup can know early
A founder can often learn enough from public sources to make the first consultant conversation sharper. The useful output is a pathway-prep packet, not a pathway decision.
- Possible device categories and product-code clues.
- Similar devices and public submission record patterns.
- Regulation citations, panel clues, exemption clues, and warning signs.
- Gaps where the startup needs qualified review before spending more money.
What the packet includes
| Packet component | What it captures |
|---|---|
| Product definition worksheet | Intended use, user, patient population, technology, environment, accessories, software, and claims. |
| FDA source ledger | Product Classification, 510(k), De Novo, PMA, exemption, and guidance links where relevant. |
| Comparator shortlist | Candidate public records and why each might or might not matter. |
| Pathway clue matrix | Possible product code, regulation clue, similar-device pattern, and source limitation. |
| Reviewer question list | Decisions that still require qualified regulatory, legal, quality, or clinical review. |
Pathway clue matrix
- Possible product code and generic category.
- Regulation citation and device class clue.
- Similar devices and public submission record pattern.
- Exemption, De Novo, 510(k), or Premarket Approval watch-out.
- Why the clue may not apply to the startup's product.
What needs qualified review
- Final classification and product-code applicability.
- Whether exemption, 510(k), De Novo, Premarket Approval, or another path should be discussed.
- Predicate suitability, testing strategy, clinical evidence, labeling, and claim boundaries.
- Quality-system, legal, reimbursement, distribution, import, and commercial launch implications.
What TrueMedDevice can prepare
TrueMedDevice prepares the pathway-prep evidence packet: public source ledger, product-code clues, similar-device shortlist, pathway clue matrix, source limitations, and open questions for the consultant or RA/QA reviewer.
Source ledger
What it can tell you
FDA's public overview of device classification and regulatory control categories.
What it cannot decide
Your product's final classification, product code, exemption, or submission pathway.
What it can tell you
How FDA describes product codes and generic device categories in the classification database.
What it cannot decide
Which product code applies to your device or whether a code is sufficient for launch planning.
What it can tell you
Public context about Class I and Class II device exemptions.
What it cannot decide
Whether your specific device, claims, or changes qualify for an exemption.
What it can tell you
FDA's public overview of the De Novo classification request pathway.
What it cannot decide
Whether De Novo is appropriate for your product or evidence strategy.
What it can tell you
Current FDA context for electronic medical device premarket submissions through the CDRH Portal.
What it cannot decide
Whether a submission is complete, sufficient, or strategically appropriate.
Frequently asked questions
Is a pathway assessment the same as a regulatory strategy?
No. This is a source-backed preparation packet for qualified strategy review. It helps a reviewer see the evidence and assumptions faster.
Can public databases prove my device is exempt?
No. They can surface exemption clues and related records, but a qualified reviewer must decide whether any exemption applies to your specific product and claims.
What is the best next step after the packet?
Use it to brief a qualified regulatory reviewer or consultant with source links, product assumptions, comparator clues, and explicit open questions.
Need a pathway-prep packet before buying full consulting?
Start with public-source evidence, product definition, product-code clues, similar-device records, and open reviewer questions before committing to a broad engagement.
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