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Maker of 'Smart Sock' for infants stops selling product after receiving warning letter from FDA

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Posted at 5:36 AM, Dec 07, 2021
and last updated 2021-12-07 08:07:00-05

MILWAUKEE — Thousands of caregivers across the country are signing a petition to get a popular baby product back on the market.

It's called the Owlet Smart Sock. It's a sleep monitoring device you put on an infant's foot and you can track their heart rate and oxygen levels. If the baby's readings aren't safe, it alerts you.

The safety of the device isn't being called into question. The FDA is taking issue with how the product is being marketed. The federal agency says the product should be marketed as a medical device and therefore needs the proper approval.

Owlet Baby Care stopped selling the product on its website after receiving a warning letter from the FDA.

In the letter, the FDA explains its product is being sold "without marketing approval, clearance, or authorization from FDA."

The federal agency says the socks should be classified as medical devices in part because they "...measure blood oxygen saturation and pulse rate..."

Mom Caitlin Needham believes the Owlet Smart Sock saved her baby Abby's life when she was a newborn. Needham says Abby woke up to nurse like normal, then Needham accidentally fell asleep.

"I woke up to the bay station alarming like it will when there's an issue with the oxygen or heart rate level, and she was pressed up against me," said Needham.

"There's a really good chance that she could have suffocated had the device not gone off," she added.

While she still uses the tracker, Needham is upset to see other parents in the United States can't buy the product directly from the company right now. So she started a petition on change.org.

"If you have a device that your baby is wearing that can tell you the moment there's an issue, why would you not want to know right when the issue occurs?" she asked.

TMJ4 reached out to the FDA as well as Owlet Baby Care for comment on this story.

A spokesperson for Owlet Baby Care pointed us to the company website where it responded.

On another part of its website, the company says it is "... actively pursuing submitting a medical device application to the FDA."

An FDA spokesperson provided the below statement, pointing us to the original letter sent to Owlet Baby Care:

"The violations to the Federal Food, Drug, and Cosmetic Act are outlined in the warning letter issued to Owlet Baby Care below:

For your background, a medical device is a device that is used as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

*intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

*recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,

*intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."

The FDA also provided the below links as part of its response.

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