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Study Finds Gaps in FDA Medical Device Event Reports
Key Takeaways
- Researchers reviewed 6,308 FDA summary reports covering 159,503 adverse events from July 2019 to June 2025.
- Fifty-five percent of reports exceeded the FDA’s 30-day reporting deadline.
- The study calls for improvements to preserve the ability to detect device-safety signals.
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DT Editorial Team··via medicalxpress.com
