Don Calogero, MSE

Don Calogero, MSE is a Biomedical Engineer who earned his Master of Science in Biomedical Engineering from SUNY at Stony Brook before serving as an FDA senior reviewer/team leader in the ophthalmic implants branch of CDRH for close to 45 years. His responsibilities in this role primarily involved the application of regulatory requirements for intraocular lenses (IOLs). In his final year at FDA, his focus was training newly hired staff. Mr. Calogero has over 30 years of experience developing clinical and non-clinical ISO and ANSI standards for ophthalmic implant devices and has served as chairman of multiple clinical and non-clinical standards. He also led a World Health Organization (WHO) effort to publish guidelines for the manufacture of IOLs in developing countries. He has extensive experience evaluating PMA, IDE, 510(k), and key labeling submissions to FDA in the areas of manufacturing/quality control processes and changes, non-clinical validation test data, and ophthalmic device contaminant levels (insoluble inorganics, endotoxin, EO residuals). He has experience reviewing the clinical study designs for IOL evaluations to conform with FDA recognized standards, determining clinical/non-clinical testing requirements associated with IOL design modifications, and evaluating specular microscopy data for ophthalmic implants (including glaucoma implants). Under Regulatory Pathways Group, Mr. Calogero provides regulatory and R&D consulting services for ophthalmic devices, including technical requirements, optical designs, manufacturing controls, quality systems, manufacturing/quality control modifications after approval, non-clinical test plans, clinical requirements/non-clinical testing associated with IOL design modifications, and clinical study design evaluations with respect to FDA recognized ISO/ANSI standards.