NIST and standards for tissue engineered medical products

On June 13-14, 2001, the National Institute of Standards and Technology (NIST) convened a workshop of high level representatives from industry, federal agencies, and standards organizations to identify standards-related needs of the biomedical materials and devices industry. There were individual breakout sessions on standards for: Biomaterials, Therapeutic and Drug Delivery Devices, Auditory Diagnostic and Prosthetic Devices, Manufacturing of Prostheses, and Tissue Engineered Medical Products (TEMPs). Cross-cutting issues of Harmonization of Standards, Data, and Sterilization were also addressed. The session on Standards for TEMPs placed its most significant needs on the development of test methods and materials characterization. Action items for NIST to consider were separated into those relative to the Food and Drug Administration (FDA) approval process and those relative to industry needs not directly related to the FDA approval process. This paper summarizes the needs identified for TEMPs and the status of NIST-related activities.