New research from our team in @bmj_latest finds that medical device adverse events are still being reported within summary reports that are frequently incomplete, inaccurate, and delayed, despite FDA's decision in 2019 to end a similar program due to transparency concerns
Permitting medical device manufacturers to submit bulk summary reports of adverse events to the US Food and Drug Administration, rather than reporting individual cases, often fails to promptly detect potential safety signals, finds new study in The BMJView quoted post on X
bmj.com/content/395/bm…