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Conexiant chevron_right Cardiology chevron_right Study Shows Widespread Delays in Medical Device Reporting to FDA
From the Journals FDA & Government News

Study Shows Widespread Delays in Medical Device Reporting to FDA

Late reporting was concentrated among a small number of manufacturers, with 3 manufacturers and 13 devices accounting for 54.8% of all late reports between 2019 and 2022.

Conexiant
article Full Article subject Summary summarize Notecard
  1. Over 1.2 million medical device adverse event reports were not promptly reported to the FDA between 2019 and 2022. 
  2. Researchers assessed the timeliness of adverse event reporting by medical device manufacturers.
  3. A significant percentage of reports were submitted late, with most delayed by over 6 months.
  4. Stricter compliance measures and greater transparency may potentially improve postmarket surveillance.

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