Tissue Engineered Medical Products Standards (TEMPS)

Introduction

The standards process for tissue engineered medical products is underway within the American Society for Testing and Materials International (ASTM) Committee F-04, Division IV Tissue Engineered Medical Products (http://www.astm.org/) of Committee F04 on Medical and Surgical Materials and Devices. Information describing the process and progress will be presented at this FDA site. Updated information and current draft documents can be viewed at (http://www.astm.org). Additional information on Tissue Engineering may be obtained at the Pittsburgh Tissue Engineering Initiative site.

Process

• The process began with a meeting in San Diego, CA Nov. 1997. At this meeting categories of importance to the field of Tissue Engineering were developed through the Hoshin process.
• A follow-up meeting at NIST, Gaithersburg, MD., on December, 1997, began the process of structuring the task groups activities.
• Rationale and justification for the development of standards was published in 1998.
• Activities culminated in a structure for the Task Groups and on-line communications enabling the development of draft documents for TEMP standards.

Working Meetings

• Working meetings are held at Committee Week in conjunction with Committee F04 Medical and Surgical Materials and Devices, semi-annually in mid November and mid May at various sites in the US, Canada and other international sites. Updated information can be obtained at www.astm.org. for Committee F04.
• Satellite meetings are scheduled as needed at other venues.

For comments on the Tissue Engineered Medical Products contact the site coordinator: david.kaplan@fda.hhs.gov.