Dr. Howard Smith Oncall

  Vidcast:  https://youtu.be/NZAh4xw4Cl4   I recently saw an ad for a portable EKG device called the KardiaMobile 6L. It’s a clever little device that permits you to record a 6 lead EKG at home. What caught my eye was the term FDA-cleared on the ad.  So I checked on the FDA’s website to find out just what that means.   The first step in the process of legal marketing of a medical device in the US is registration with the FDA.  If an FDA Registered medical device is substantially similar to a medical device previously registered, proven by rigorous testing to safe and effective, and approved by the FDA, it becomes FDA Cleared for marketing.  A device that is only FDA Cleared has itself not been subjected to the rigorous testing necessary to be labeled FDA-Approved.  If a device is not obviously similar to one approved, the FDA can still grant it an administrative clearance for marketing, the the device will be deemed FDA Granted.  Only devices that have undergone controlled testing and proven beyond a doubt sa