If you spend any amount of time in this business, you no doubt woke up this morning with your Twitter feed loaded with “What the FDA’s Latest Letter Teaches Us About Mobile” tweets. I did.
Let me boil it down for you. Nothing. It teaches us nothing. No, I take that back. If you happen to be the one person left in the universe that doesn’t understand that in order to market any kind of diagnostic device in the United States, it first must be submitted and gain approval from the FDA, then good news! Today has a teachable moment just for you.
In case you missed it, the FDA issued an “It Has Come To Our Attention” letter to Biosense Technologies Private Limited concerning it’s uChek Urine Analyzer. Apparently, BTPL went to market with a smart phone version of a urine stick analysis tool without running it by the FDA first. Or, as noted in their letter, it may just be that FDA can’t find the paperwork.
“We have conducted a review of our files, and have been unable to identify any Food and Drug Administration (FDA) clearance number for the uChek Urine analyzer. We request that you provide us with the FDA clearance number for the uChek Urine analyzer. If you do not believe that you are required to obtain FDA clearance for the uChek Urine analyzer, please provide us with the basis for that determination.”
2 things here. First, the reason BTPL got a letter was for (maybe) acting in violation of the rules and guidelines that have existed before smart phone devices began being regulated. The only reason people are posting anything about this is the fact that the words “mobile phone” appear in the letter. Second, you will probably get an email or tweet today that suggests that you need to contact X,Y, or Z person as this “new guidance” should require some great consultation to rethink your mobile strategy. Let me save you some time and suggest that their council will be much ado about nothing as well.