Ohio Devicemaker Draws FDA Warning

The FDA has issued a warning letter to Klarity Medical Products following an inspection of its facility in Newark, Ohio.

The agency investigators found that the company lacked premarket approval for its Klarity BiteLok device, which had been added to the firm’s FDA-cleared thermoplastic body support device for use during radiation therapy.

The company said the addition of BiteLok was a design change. But the FDA said the BiteLok device is a different device than the already-approved thermoplastic mask and requires its own premarket clearance.