WARNING LETTER
Owlet Baby Care, Inc.
MARCS-CMS 616354 —
October 05, 2021
Product:
Medical Devices
Recipient:
Recipient Name
Mr. Kurt Workman
Recipient Title
Chief Executive Officer
Owlet Baby Care, Inc.
2500 Executive PKWY Suite 500
Lehi
,
UT
84043
United States
kworkman@owletcare.com
Issuing Office:
Center for Devices and Radiological Health
United States
October 5, 2021
CORRECTION
WARNING LETTER
Re:
Owlet Smart Sock Family (version/generation 1, 2, 3, Smart Sock Plus, and co-packaged products (e.g., Owlet Monitor Duo (Smart Sock + Camera), referred to herein as “Owlet Smart Socks”))
Refer to
CPT2000580_CMS 616354
Dear Mr. Workman:
This is an amendment to the letter dated October 1, 2021.
The United States Food and Drug Administration (FDA) has learned that your firm is marketing Owlet Smart Socks in the United States without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
Under section 201(h) of the Act, 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body. Products that measure blood oxygen saturation and pulse rate are devices when they are intended to identify (diagnose) desaturation and bradycardia and provide an alarm to notify users that measurements are outside preset values.
FDA has reviewed your firm’s web site, multiple commercial websites, and your firm’s responses to FDA correspondence and determined that the Owlet Smart Socks are offered for sale in the United States without marketing approval, clearance, or authorization from FDA. Accordingly, your products are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g) for the device as described and marketed. The introduction or delivery for introduction of an adulterated or misbranded device into interstate commerce is prohibited under section 301(a) of the Act, 21 U.S.C. § 331(a).
Marketing examples captured on or about 07/22-26/2021 include:
Amazon Web Site: https://www.amazon.com/Owlet Smart Sock 3
o “Track the most important indicators of your baby’s health–like oxygen level, heart rate, and total hours slept”
o “If your baby’s readings leave preset “safe” zones, the Smart Sock will immediately notify you that your baby needs your attention.”
Owlet Sales: https://owletcare.com/
o “We look at the best indicators of your baby’s overall well-being and will proactively notify you if your baby may need you.”
o “Track heart rate, oxygen level, and sleep trends.”
Walmart Sales: https://www.walmart.com/ip/Owlet-Smart-Sock-Baby-Monitor/167836816
o “Owlet Smart Sock 2 Baby Monitor, Tracks Heart Rate & Oxygen”
o “Rest easy knowing you’ll receive proactive notifications via lights and sounds if your baby’s oxygen level or heart rate leave preset zones
o View real-time heart rate and oxygen level and receive notifications from any connected device using the Owlet app
Target Sales: https://www.target.com/p/owlet-smart-sock-3-baby-monitor-with-oxygenheart-rate/-/A-83704325?preselect=79727730#lnk=same tab
o “Owlet Smart Sock 3 Baby Monitor with Oxygen & Heart Rate”
o “Tracks the baby’s heart rate and oxygen level
o Tells you when Baby needs you
o Measures how long and how well the baby slept
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).
For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency. 21 CFR 807.81(b). The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm
. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
Our office requests that Owlet Baby Care, Inc. cease any activities that result in the adulteration of the Owlet Smart Sock (All versions and co-branded products), such as the commercial distribution of the device for the uses discussed above.
Your firm should take prompt action to address any violations identified in this letter. Failure to adequately address this matter may result in regulatory action being initiated by the FDA, including, but not limited to, seizure, injunction, and civil money penalties.
Other federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal contracts.
This letter notifies you of our concerns and provides you with an opportunity to address them. After you receive this letter, please notify this office in writing within fifteen (15) business days from the date you receive this letter of the specific steps your firm has taken to address any violations, as well as an explanation of how your firm plans to prevent any violations from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address any violations included in this Warning Letter. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.
Your firm’s response should be sent by email to: CDRHWarningLetterResponses@fda.hhs.gov or by mail to:
Food and Drug Administration
Center for Devices and Radiological Health
Office of Regulatory Programs
Division of Regulatory Programs 2: Establishment Support
Regulatory Inspections and Audits Team
White Oak Building 66
10903 New Hampshire Ave.
Silver Spring, MD 20993
Refer to the identification number
CPT2000580 and CMS 616354
when replying. We remind you that only written communication is considered as official. If you have any questions about the contents of this letter, please contact Todd Courtney at 301-796-6371 or Todd.Courtney@fda.hhs.gov.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm. It is your firm’s responsibility to ensure compliance with the applicable laws and regulations administered by FDA.
Sincerely,
/S/
Malvina Eydelman, M.D.
Director
OHT 1: Office of Ophthalmic, Anesthesia,
Respiratory, ENT and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
cc:
Jutika Gokarn
Sr. Director of Quality Engineering and Risk Management
Owlet Baby Care, Inc.
jutika.g@owletcare.com
(b)(6)
Content current as of:
10/26/2021
Regulated Product(s)
Medical Devices