Pre-production brief
| Field | Definition |
|---|---|
| Reader | Founder or first RA/QA owner checking one device before a consultant call. |
| Trigger | A similar device, supplier, product family, or familiar device needs safety-history context. |
| Blocked decision | The team does not know whether public FDA records change the review questions. |
| Useful output | A dated FDA safety-history scan with source links, query terms, themes, limits, and owner questions. |
What the scan should contain
- Device and manufacturer names searched.
- Product-code or similar-device clues used to widen or narrow the query.
- MAUDE themes, with the limitation that reports are not incidence rates or adjudicated safety conclusions.
- Recall and correction records, with classification status and source date preserved.
- Warning-letter context, if the company, device family, or issue appears relevant.
- Open questions for qualified reviewers.
What not to conclude from the scan
A public safety-history scan is a review artifact, not a safety determination. The same public record can be irrelevant, incomplete, stale, or important depending on device facts that are not visible in the public database.
The output should therefore preserve uncertainty: what was searched, what was found, what was not found, what each source can and cannot show, and who owns the next decision.
What TrueMedDevice can prepare
TrueMedDevice can prepare a dated FDA safety-history scan with MAUDE, recall, warning-letter, and database-source links; search terms; relevant themes; source limitations; and owner questions.
Source ledger
What it can tell you
Public medical device adverse-event report narratives and searchable report fields.
What it cannot decide
Whether a device is unsafe, whether an event is verified, or whether a product-specific action is required.
What it can tell you
FDA-classified recall records and correction or removal actions in the public recall database.
What it cannot decide
Whether a new issue is reportable, whether a product must be recalled, or whether a similar device has the same risk.
What it can tell you
Public FDA warning-letter records and the issues FDA described in those letters.
What it cannot decide
Whether another company or device has the same compliance status or enforcement risk.
What it can tell you
FDA's public database entry points for device research.
What it cannot decide
Which database result is product-specific, clinically meaningful, or sufficient for a regulatory decision.
Frequently asked questions
Are MAUDE reports proof that a device is unsafe?
No. MAUDE reports are public adverse-event reports, not verified incidence rates or device-specific safety conclusions. They are useful as review signals when the query, source, date, and limitation are preserved.
Should I search recalls by brand name or product code?
Use both when appropriate. Brand-name searches can miss adjacent records, while product-code searches can over-include. The scan should record both the query path and why each result is in or out of scope.
Does this replace RA/QA or complaint review?
No. It prepares public-source context for qualified reviewers. Reportability, recall, complaint, safety, compliance, and clinical decisions remain with the responsible owners.
Need a dated FDA safety-history scan before the consultant call?
TrueMedDevice can organize the MAUDE, recall, warning-letter, source-limit, and owner-question packet before paid review time starts.
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