The main priority of the FDA Human Tissue Task Force (HTTF) will be to assess effectiveness of the new human tissue regulations, which went into effect in 2005. Of particular interest will be a review of recently reported findings that some tissue recovery businesses are not following federal requirements for tissue recovery.
The primary goal of HTTF is to identify whether any additional steps are needed to further protect the public health while assuring the availability of safe products.
While the FDA believes most firms involved in tissue manufacturing comply with the new regulations, the agency wants to further explore what additional steps could make sure firms follow required practices to prevent the transmission of communicable diseases.
The FDA continues to identify and, where appropriate, take action against those that violate the rules. These actions may include both administrative and criminal proceedings.
Within the next three months, the task force will develop an action plan to propose changes to existing policies, as well as generate a set of recommendations, identify what resources are needed to support these actions and report on how the agency can immediately implement the action plan.
