COMPANY MUST STOP SELLING DEVICES OTC, FDA SAYS
Splintek, a division of Power Products, must stop marketing its Sleep Right adjustable night guard for OTC purchase because the company did not gain premarket approval to sell the device without a prescription, an FDA warning letter said.
The company is selling the device OTC and marketing it for use in children ages 12-18, according to the Jan. 16 letter. However, Splintek only has agency approval to market the device for prescription use in patients older than 18, according to the letter, posted Jan. 30 to the FDA website.
Marketing the device without the correct premarket approval (PMA) application makes the night guard adulterated, the warning letter said. In addition, failing to submit a PMA application meant Splintek did not inform the agency of its intent to sell the device OTC, making the night guard misbranded, the letter added.
The warning letter can be seen at www.fda.gov/foi/warning_letters/g6211d.pdf (http://www.fda.gov/foi/warning_letters/g6211d.pdf).