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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Summer Infant, Inc.

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 10903 New Hampshire Avenue
Silver Spring, MD 20993
 

AUG 12, 2010
 

Warning Letter

VIA United Parcel Service

Jason P. Macari
Summer Infant, Inc.
10 Hannah Drive
Cumberland, Rhode Island 02864

RE: Mother's Touch® Sleep Positioner
Head-n-Back® Sleep Positioner
The Resting Up® Sleep Positioner
Supreme Sleep Positioner with Heartbeat
 

Dear Mr. Macari:

Refer to GEN0900704 when replying to this letter.

The Food and Drug Administration (FDA) has learned that your firm is marketing Mother's Touch® Sleep Positioner, Head-n-Back® Sleep Positioner, Supreme Sleep Positioner with Heartbeat, Resting Up® with Heartbeat Sleep Positioner, and Symmetry Sleep Positioner in the United States (U.S.) without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).

The Office of Compliance (OC) in the Center for Devices and Radiological Health (CDRH) reviewed http://www.summerinfant.com/categories-products-view for Mother's Touch®
Sleep Positioner, Head-n-Back® Sleep Positioner, Supreme Sleep Positioner with Heartbeat, Resting Up® with Heartbeat Sleep Positioner, and Symmetry Sleep Positioner. These
products are devices within the meaning of section 201(h) of the Federal Food, Drug, and Cosmetic Act. According to your website,

"The Mother's Touch® Sleep Positioner is designed to keep baby centered in the crib and sleeping comfortably on his back... The positioner also includes the TOTS reminding system to help parents remember to alternate the direction in which they lay baby down to help prevent Plagiocephaly, or Flat Head Syndrome."

"The Head-n-Back® Sleep Positioner is designed to keep baby centered in the crib and sleeping comfortably on his back... The Head-n-Back® Sleep positioner includes the TOTS reminding system to help parents remember to alternate the direction they lay baby down to sleep, which helps prevent Plagiocephaly, or Flat Head Syndrome."

"The Resting Up® Sleep Positioner offers an inclined sleep surface for your baby to aid in digestion... The Resting Up® Sleep Positioner includes the TOTS reminding system. This system to help parents remember to alternate the direction they lay baby down to sleep, which helps prevent Plagiocephaly, or Flat Head Syndrome."

"The Supreme Sleep Positioner with Heartbeat creates a custom cradle for your baby...The gentle incline elevates baby's head to help digestion... The Supreme Sleep Positioner with Heartbeat includes the TOTS reminding system to help parents remember to alternate direction they late (lay) baby down to sleep. This helps prevent Plagiocephaly, or Flat Head Syndrome"..

These devices are adulterated under section 501 (f)(1)(B) of the Act, 21 U.S.C. 351 (f)(1)(B), because you do 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). These devices are also misbranded under section 502(o) of the Act, 21 U.S.C. 352(o), because you did not notify the agency of your intent to introduce the device into commercial distribution, as required by sections 510(k) of the Act, 21 U.S.C. 360(k).

You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to seizure, injunction, and/or civil money penalties.

Please submit a written response to this letter within 15 working days from the date you receive this letter, describing your intent to comply with this request. Please direct your response to Valerie A. Flournoy at the Food and Drug Administration, 10903 New Hampshire Avenue, W066-3521, Silver Spring, MD 20993 facsimile at (301) 847-8137. We remind you that only written communications are considered official.

The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your Mother's Touch® Sleep Positioner, Head-n-Back® Sleep Positioner, Resting Up® Sleep Positioner, and Supreme Sleep Positioner with Heartbeat comply with each applicable requirement of the Act and FDA implementing regulations.
 

Sincerely yours,
/S/
Timothy A. Ulatowski
Director
Office of Compliance
Center for Devices and
Radiological Health
 

cc:
Stephen Bracewell
Summer Infant, Inc.
1275 Park East Drive
Woonsockett, Rhode Island 02895

Anthony A. Paolo
Summer Infant, Inc.
1275 Park East Drive
Woonsockett, Rhode Island 02895

Steven I. Rosenbaum, Esq.
Poore & Rosenbaum, LLP
30 Exchange Terrance
Providence, Rhode Island, 02903