Data-Driven Tools to Accelerate the Clinical Translation of Novel Dental, Oral, and Craniofacial Biomaterials (R61/R33 - Clinical Trial Not Allowed)

archived

The goal of this FOA is to solicit applications to accelerate development, testing and implementation of advanced data-driven tools specifically designed to overcome critical problems affecting research and development (R and D) cycles that might contribute to delays in regulatory approval and human use of novel biomaterials for dental, oral, and craniofacial (DOC) applications. It is part of a suite of FOAs that encourage applicants to leverage the FDA-CDRHs Medical Device Development Tools (MDDT) Program framework as an innovative and important pathway to ensure that outcomes of funded studies yield practical and validated tools that are qualified by FDA to support a particular context-of-use. The overall objectives are to: 1) accelerate R and D cycles of biomaterials for DOC applications by de-risking potential safety and effectiveness uncertainties through robust and predictive preclinical characterization; 2) support technical developments and validation activities needed to satisfy the FDA MDDT qualification process for proposed data-driven tools; 3) promote multi-domain collaborations and empower workforce development at the intersection of data-driven technologies and biomaterial science in dentistry; and 4) build confidence in the use of data-driven technologies in biomaterials innovation by establishing pipelines of robust and validated tools that are qualified by FDA.

High