A recent JAMA Internal Medicine editorial takes another swipe at the FDA for delays in improving its medical device adverse-event reporting. Journal editor Dr. Rita Redberg and Dr. James Salazar, both of Department of Medicine, University of California, San Francisco, note several instances in which information was withheld from the public or not reported in full detail. The editorial also highlights two studies published in the Dec. 20, 2019 issue, one about nationwide experience in Iceland of adverse events related to St. Jude Medical’s Riata defibrillator lead, and the other about “the high burden of serious adverse events (including death)” with Medtronic’s InSync III model 8042 heart failure pacemaker. The InSync II article notes the length of time the FDA took from the first notice of device failure (19 months) to a recall of the device, and the FDA’s decision to classify the recall as Class II, which denotes a low probability of serious adverse events. “This long unexplained delay before the recall and the inappropriate recall classification raise concerns about patient harms that could have been prevented by speedier and stronger regulatory actions,” Redberg and Salazar...