Back to: FDA Regulatory Education for Industry (REdI) 2024 Conference – Devices Track
Presenter
Simon Choi, MPH, PhD
Senior Policy Advisor
Division of Standards and Conformity Assessment (DSCA)
Office of Readiness and Response (ORR)
Office of Strategic Partnerships and Technology Innovation (OST)
Center for Devices and Radiological Health (CDRH)
U.S. Food and Drug Administration (FDA)
Simon Choi is a Senior Policy Advisor with the Division of Standards and Conformity Assessment (DSCA) in CDRH’s Office of Readiness and Response (ORR), in the Office of Strategic Partnerships and Technology Innovation (OST). He has led major public health projects and initiatives at FDA for medical imaging, directed computed tomography (CT) medical imaging safety investigations and developed regulatory policies for Digital Health. Previously, Dr. Choi was Director of the Master of Public Health program at the University of Kansas Medical Center and served as Assistant Professor in the Department of Preventive Medicine. Dr. Choi received a Masters and PhD in Public Health from the University of Southern California.
Abstract
Simon Choi’s presentation highlights how leveraging consensus standards and the voluntary ASCA program can significantly streamline medical device development and FDA pre-market review. He explains that using FDA recognized standards is encouraged as it provides confidence that device claims are met and can reduce documentation burden compared to “general use” of standards which often requires complete test reports. The Accreditation Scheme for Conformity Assessment (ASCA) program, which is now permanent, further simplifies the process by utilizing accredited test labs; submissions using ASCA-accredited testing and declaring conformity generally require only a summary test report, leading to fewer deficiencies and faster FDA review times. Applicable recognized standards can be found using the recognized standards database, searchable by product code. While participation is voluntary, using recognized standards and ASCA offers substantial benefits, and they can be easily cited and completed within the eSTAR submission template.