Having started my career in mass torts, one of the first things I learned about was the U.S. Food and Drug Administration (FDA) 510(k) clearance process regarding a medical device. It wasn’t until very recently (late November 2017 to be exact) that I realized how little the general public knows about this process. I was watching one of my favorite TV shows, “Chicago Med,” which focuses on the emergency department at a fictional hospital, Gaffney Chicago Medical Center, and its doctors and nurses, when the following scene took place (I am no screenwriter so I’ll do my best to set the stage):

Dr. Connor Rhodes, a cardio-thoracic surgeon, arrives to the hospital late due to some stress at home. He’s immediately presented with a former patient who is complaining of coughing and wheezing. Dr. Rhodes is perplexed as he had just replaced this patient’s aortic valve two weeks ago without complication. A colleague and trauma surgeon, Dr. Ava Bekker, instantaneously makes a presumption that Dr. Rhodes must have done something wrong, like misorient the valve, especially because of all the personal drama he is dealing with at home. But Dr. Rhodes assures her this is not possible as the surgery went off without a hitch.

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