Pre-production brief
| Field | Answer |
|---|---|
| Reader | Founder or first RA/QA hire preparing a 510(k) consultant review. |
| Trigger | The team is about to spend paid review time on predicate or pathway questions. |
| Blocked decision | Which public records matter before asking whether a candidate predicate strategy is plausible. |
| Useful artifact | Product Evidence Map with source links, comparison rows, and owner questions. |
Reviewer workflow
- Write the current intended-use statement before searching records.
- List candidate product-code clues with source URLs and date checked.
- Build a K-number shortlist and summarize indication and technology differences.
- Attach safety-history prompts for recalls, MAUDE, warning letters, and safety communications.
- Leave final predicate, pathway, and substantial-equivalence judgments to qualified reviewers.
Map fields that prevent false confidence
| Map field | Why it matters |
|---|---|
| Intended use | A similar name is not enough if the intended use differs. |
| Technological characteristics | The same product code can still hide meaningful design differences. |
| Safety history | Recalls and adverse-event signals may frame reviewer questions. |
| Standards and guidance | Device-specific guidance can change what evidence the packet should collect. |
What TrueMedDevice can prepare
TrueMedDevice can prepare the source ledger, product-code clues, candidate K-number list, comparison rows, safety-history prompts, and consultant handoff questions.
Source ledger
What it can tell you
Candidate product-code, regulation, and classification clues for a device description.
What it cannot decide
The final product code, class, predicate, pathway, or substantial-equivalence argument.
What it can tell you
Public 510(k) records that may support a candidate similar-device or predicate shortlist.
What it cannot decide
Whether a cleared device is an acceptable predicate for a new device.
What it can tell you
FDA's public guidance on predicate-device research and use in a 510(k) context.
What it cannot decide
Whether the candidate predicate set is sufficient for a specific submission.
What it can tell you
Public recall context for candidate similar devices or product families.
What it cannot decide
Safety, risk acceptability, or whether a predicate remains appropriate.
Frequently asked questions
Does a Product Evidence Map pick my predicate?
No. It organizes candidate evidence and questions. Predicate selection and substantial-equivalence strategy remain qualified review decisions.
What should be in the map before a consultant call?
At minimum: intended use, product-code clues, candidate K-numbers, comparison notes, safety-history prompts, source URLs, and unresolved questions.
Why include safety history in a predicate map?
Safety signals do not decide predicate fit, but they can help reviewers frame risk, labeling, testing, and post-market questions.
Need a Product Evidence Map before the consultant call?
TrueMedDevice can organize source links, candidate records, comparison rows, and owner questions into one review-ready packet.
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