Trends in the FDA

Abstract

A skin-replacement product for patients with severe burns was the first FDA-approved tissue- engineered product. Since that time, tissueengineered skin replacements have been approved for treatment of diabetic ulcers and reconstructive surgery. Other tissue-engineered products are in development or in clinical trials to serve as substitutes for missing or defective cartilage, bone, blood vessels, cardiovascular tissues, ligaments, tendons, nerve guides, and muscle. The challenges facing scientists, developers, and regulatory agencies are ensuring that the replacement tissues are safe and efficacious. In instances such as bone, where tissue growth is slow, a meaningful surrogate endpoint must be defined to measure efficacy. Further challenges include the design and verification of noninvasive or minimally invasive tests to measure short-and long-term functionality. As noted above, the FDA is working with other government agencies and private-sector groups to help establish consensus standards for use in the approval process for medical devices. This activity, together with the use of legally constituted third-party reviewers, will continue to expedite the process of bringing new tissueengineered products to the market place.