The FDA is Back and Coming after Smart Socks

Source: American Institute for Economic Research
by Raymond J March

“This October, the agency sent a warning letter to Owlet regarding its very popular Smart Sock – which monitors a baby’s pulse and oxygen levels while it sleeps. The letter states that the FDA now considers the product to be a medical device — requiring it to be approved before it can be legally sold on the market. Consequently, Owlet was asked to remove its product from the market or face ‘seizure, injunction, and civil money penalties.’ But why is the FDA coming after the Smart Sock now? Owlet’s product has been on the market since 2015 — releasing three additions and helping to monitor over 600,000 infants while earning the trust of millions of parents. It’s also commonly used in the UK, Canada, and New Zealand where it has never generated safety or efficacy concerns. Perhaps more confusing than the FDA’s strange timing is its willingness to remove a product that literally saves lives.” (11/10/21)