CERSI P.I.s and Collaborators: Lex Schultheis, MD,Ph.D., William Bentley, Ph.D., UMCP
FDA SMEs and Collaborators: Jorge Hernandez, M.S., James Coburn, M.S., CMDR USPHS, Matthew Diprima, Ph.D., CDRH
A key goal is to study AM printed products and develop process controls for safe manufacture and confirm chemical and mechanical structure. Additively manufactured products are now being manufactured as dental surgery guides, for use as cell culture expansion scaffolds and for drug-release combination products. AM can be conducted without qualification of feedstock materials, quality systems management over final finished products or premarket regulatory review. Uncertainties about post processing of AM parts can affect product chemistry and mechanical integrity. Our work will inform FDA reviewers about potential hazards or practices likely to be safe.