New Biomaterials: Essential Steps to Clearing Regulatory Hurdles

Orthopedic devices comprising new biomaterials necessitate a complex regulatory and product development testing plan. The decision tree begins with the answers to three key questions. Is your new biomaterial considered a drug by the regulating authority? Is your biomaterial permanent or absorbable? Are one or more of the constituents of the biomaterial truly new for first-time use in an orthopedic device? This presentation outlines ways to develop an efficient, successful regulatory and development plan, including a definition of the regulatory path, data requirements, consensus standards for materials and testing, scientific literature and the time and money to execute. Dr. Poggie also provides case studies based on his decades of experience in working with new materials.

Learning Objectives

• Knowledge of decision trees to define regulatory path and test requirements for permanent and absorbable biomaterials
• Resources to reference: FDA guidance documents and consensus standards to apply to testing of the device and biomaterial
• Timelines and costs associated with critical gating items such as ISO 10993 evaluation of biocompatibility and functional animal modeling of the clinically intended use
• Performance characteristics and materials properties that are important to the regulatory test plan, and in turn, planned in vitro tests
• How to leverage scientific data and predicate device information

Speaker