TEI Biosciences, Inc. – FDA Warning Letter

On May 29, 2015, the FDA issued a Warning Letter to TEI Biosciences, Inc. regarding their SurgiMend surgical mesh. The FDA determined that SurgiMend is being marketed in the U.S. without proper marketing clearance or approval, violating the Federal Food, Drug, and Cosmetic Act.

Specifically, the device is adulterated under section 501(f)(1)(B) of the Act because TEI Biosciences lacks an approved premarket approval (PMA) or investigational device exemption (IDE) for SurgiMend as currently described and marketed. Furthermore, the device is misbranded under section 502(o) of the Act because the firm introduced it into interstate commerce with major changes to its intended use without submitting a new premarket notification (510(k)).

The SurgiMend was cleared under K083898 for general soft tissue reinforcement and hernia repair. However, the firm's website promotes the device for breast surgery applications, stating, "The superior biologic matrix for your breast surgery patients." This constitutes a major change in intended use, as surgical mesh has not been cleared or approved for breast reconstruction using a tissue expander or implant, and it falls outside the general soft tissue reinforcement indication regulated by 21 CFR 878.3300.

The FDA requested that TEI Biosciences immediately cease activities resulting in the misbranding or adulter