FDA Evidence Integration

VACScore incorporates comprehensive FDA data to provide regulatory context for device evaluation.

FDA Data Sources

• Medical device adverse event reports from the MAUDE database provide insight into post-market safety signals.
• 510(k) clearance data shows regulatory pathway and substantial equivalence determinations.
• Pre-Market Approval data provides insight into devices requiring clinical evidence for approval.
• FDA recall database integration surfaces historical recall events and classifications.

How We Use FDA Data

FDA data is used to provide regulatory context—not to calculate risk rates or make clinical predictions.

Important Limitations

FDA data has inherent limitations including underreporting, reporting biases, and incomplete information. VACScore presents this data transparently.

Full Transparency

Every FDA data point used in scoring is traceable and auditable in your VACScore reports.

FDA data is updated regularly to ensure current information is reflected in scoring.