5 Key Takeaways

• 1

  Over 1.2 million medical device adverse event reports were not reported to the FDA within the required 30-day timeframe.

• 2

  The study analyzed 4,432,548 initial reports from 3,028 manufacturers for compliance with FDA's reporting requirements.

• 3

  71.0% of reports were submitted on time, while 9.1% were submitted after 180 days.

• 4

  Late reporting was concentrated among a few manufacturers, with 3 manufacturers accounting for 54.8% of late reports.

• 5

  Higher-risk devices showed greater delays, with 22.4% of Class III device reports submitted late.