FDA WARNING_LETTER - Human Biosciences, Inc. - October 18, 2011

On May 10, 2012, the FDA issued a Warning Letter to Human Biosciences, Inc. following an inspection from September 7 to October 18, 2011, at their Gaithersburg, Maryland facility, where they manufacture SkinTemp II wound dressings. The FDA determined SkinTemp II is a device under 21 U.S.C. § 321(h).

The letter states that SkinTemp II was cleared under 510(k) numbers K913023 and K925545 for wound management, with specific labeling restrictions, including not claiming accelerated healing, long-term use, or being a treatment/cure for wounds.

The FDA found that the firm's brochure, "Kollagen Technology featuring Medifil II and SkinTemp II," and website (www.humanbiosciences.com) made claims such as "Fibrillar Collagen Helps in Every Phase of Wound Management," "Activate the healing process with Kollagen," and "Collagen is known to have antimicrobial properties; hence SkinTemp II dressings help prevent microbial infection." These claims represent a major change in the device's intended use, rendering SkinTemp II adulterated under 21 U.S.C. § 351(f)(1)(B) because the firm lacks an approved premarket approval (PMA) or investigational device exemption. The device is also