Sessions
Unique Device Identifiers: FDA on UDI-DI and the importance of data quality
11:45 AM - 12:15 PM Mon
Dr. Valdes is a Biomedical Engineer /Policy Analyst working in the UDI Team in the Office of Regulatory Programs (ORP), Division of Surveillance Support in the Center for Devices and Radiological Health (CDRH) at FDA. In this role, she supports both external and internal stakeholders with challenging policy questions regarding UDI, its implementation and adoption. Before joining the UDI Team, Thelma worked in ORP, Division of submission support, where she supported the accurate and consistent policy review of pre-market submissions, in particular Q-subs, PMAs, and HDEs. Prior to that, Thelma was a pre-market lead reviewer for 10 years, working in the Office of Health Technology (OHT) 3 for all types of pre-market submissions (510ks, Pre-submissions, PMA/HDE and PMA/HDE supplements, IDEs). She developed expertise in urological products, including male and female incontinence, devices to treat benign prostatic hyperplasia, gastrointestinal devices, as well as drug/device combination products. Prior to joining FDA, she was a senior engineer in a major medical device company, working on early stage product development. She obtained her Ph.D. in Biomedical Engineering from the University of Connecticut and was a visiting scholar at the University of Seattle, WA, conducting research in Biomaterials/Tissue Engineering.