FDA EIR - LifeCell Corporation - November 12, 2010

An FDA inspection of LifeCell Corporation, located in Somerville, NJ, took place from November 2 to November 12, 2010. This high-priority inspection, focused on sponsor monitoring activities, identified a key compliance concern regarding the company's medical device, Strattice. The central issue involved the use of Strattice in the PriSm study for preventing parastomal hernias. The Food and Drug Administration (FDA) determined that this application fell outside the device's approved Instructions for Use (IFU), which permits Strattice for repairing hernias and body wall defects where reinforcing material is necessary. Contrary to this, the PriSm study protocol indicated that such reinforcement was "not required and is not considered standard of care practice" for parastomal hernia prevention. This discrepancy led the FDA to conclude that an Investigational Device Exemption (IDE) should have been secured before commencing the study, in accordance with regulations like 21 CFR 812.20(a)(1) for unapproved device uses. During discussions, company management contended that the study aimed to gather clinical data on Strattice's use for reinforcing weakened abdominal wall areas, consistent with its general purpose as a soft tissue patch. However, the FDA upheld its position, emphasizing the protocol's statement that reinforcement was not standard for the specific indication under investigation. Consequently, LifeCell Corporation was mandated to provide a comprehensive memo justifying their approach to using Strattice for abdominal wall ostomy site reinforcement.