7 ms·
Gosh he's describing the Owlet which is an amazing device and I am glad exists and the FDA sure isn't
by wittyusername 4y ago
Gosh he's describing the Owlet which is an amazing device and I am glad exists and the FDA sure isn't
- sbelskie 4y agoWhy is FDA against the device? Honestly curious.
- roguecoder 4y agoThey didn't follow the laws that govern medical devices & were marketing it with claims they didn't have the support for: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/owlet-baby-care-inc-616354-10052021 https://www.fda.gov/inspections-compliance-enforcement-and-c...
- MichaelZuo 4y ago"Since 2016, the FDA has corresponded with Owlet that the Owlet Smart Sock meets the definition of a device under the FD&C Act and does not fall under the compliance policy for low-risk products that promote a healthy lifestyle (General Wellness guidance)." Yikes it does seem that they were playing games with their marketing and stringing the FDA along.