Evidence-based decision support
Original evidence comes before conclusions
What is the authoritative product, trial and regulatory-record status?
Priority source classes
- FDA device database
- ClinicalTrials.gov
- product manufacturer registration
| Named source | Use case | Limitations |
|---|---|---|
| U.S. FDA device recall public API | FDA device database | Confirm identity, recency, original status and completeness before reliance. |
| US FDA clinical trials via ClinicalTrials.gov | ClinicalTrials.gov | Confirm identity, recency, original status and completeness before reliance. |
| openFDA status and data currency | product manufacturer registration | Confirm identity, recency, original status and completeness before reliance. |
Verification and negative evidence
- Confirm publication timestamp versus underlying record effective date.
- Do not infer no adverse record from an unsuccessful search; document search spelling and access.
- Use independent original records when a single platform aggregates primary material.
- Store source URL, date read, exact excerpt, jurisdiction and access constraints.
- Test at least one plausible contradictory hypothesis.