Pre-production brief
| Field | Answer |
|---|---|
| Reader | Founder or first RA/QA hire preparing similar-device research. |
| Trigger | A consultant call is coming and the team needs to show how public FDA records were searched. |
| Blocked decision | Which records are worth qualified predicate or comparison review. |
| Useful artifact | Dated similar-device shortlist with source URLs, search terms, comparison notes, and open questions. |
Reviewer workflow
- Start from the device description and intended use, then search candidate product-code clues.
- Query the 510(k) database by product code, device name, applicant, and decision date where relevant.
- Record K-number, product code, applicant, device name, indications, and source URL for each candidate.
- Compare intended use and technology in plain language before asking about predicate fit.
- Route predicate and substantial-equivalence questions to qualified RA/QA or a consultant.
Same-looking devices still need review
A product can look similar in a database and still differ in intended use, patient population, operating principle, software function, materials, sterilization, cybersecurity, or labeling.
The workflow should preserve those differences instead of hiding them. A shortlist is useful only if reviewers can see what is the same, what is different, and what remains unverified.
What TrueMedDevice can prepare
TrueMedDevice can prepare the search log, candidate product-code notes, K-number shortlist, comparison table, source ledger, and open predicate questions.
Source ledger
What it can tell you
Public 510(k) records, K-numbers, applicant names, decision dates, and summary links.
What it cannot decide
Whether one record is a suitable predicate for a specific new device.
What it can tell you
Candidate product-code and regulation clues to structure similar-device research.
What it cannot decide
Final classification, product code, pathway, or submission type.
What it can tell you
FDA's public explanation of predicate-device research and predicate use.
What it cannot decide
Predicate adequacy or substantial equivalence for a specific device.
What it can tell you
Programmatic access patterns for FDA public datasets when research needs scale beyond manual lookup.
What it cannot decide
The meaning or regulatory significance of a search result without review.
Frequently asked questions
Does finding similar 510(k) records mean I found my predicate?
No. It means you found candidate records for review. Predicate suitability requires qualified assessment of intended use and technological characteristics.
What should I bring to a consultant from the search?
Bring search terms, product-code clues, K-numbers, source URLs, comparison notes, and the questions you could not answer from public records.
Can openFDA replace a consultant?
No. openFDA can help retrieve public data, but it does not interpret predicate fit or submission strategy.
Need a similar-device shortlist before the consultant call?
TrueMedDevice can organize FDA search terms, candidate K-numbers, comparison rows, and open predicate questions into one packet.
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