Overview of FDA Regulation of Software Contained in Medical Device

About the Speaker

Dr. Dexiu Shi, a physicist and vision scientist, served as the senior medical device reviewer at FDA (CDRH) from 2000 to 2020 in the diverse areas: Physics/Optical Science, Biomedical Engineering, Electric Safety & EMC (Electromagnetic Compatibility), Software and Cybersecurity, especiallyfor Ophthalmic, Neurological, and ENT devices. Dr. Shi reviewed all kinds of medical device applications including 510(k), PMA, IDE, De Novo, HDE, Breakthrough, AI and Digital Health and Combination (Drug-Device) products. Dr. Shi had been nominated as FDA Liaison Representative and Technical Expert to a variety of standard committees, such as ISO, IEC, AMMI & ANSI, participating in the development of national and international consensus standards and guidelines. Dr. Shi received her MS & PhD in Biomedical Engineering from Duke University. Before joined FDA, she engaged in vision science research at the Northwestern University and Yale Medical School.

Dr. Shi currently provides consulting service for medical device regulation and advanced technology.

Learning Objectives

FDA Regulation of Medical Device Software

Premarket Submissions for Software Contained in Medical Devices

FDA Digital Health Regulatory Policies

- FDA Policy for Device Software Functions and Mobile Medical Applications

- Digital Health Policy Navigator

Challenges with Software as a Medical Device (SaMD)

- Clinical evaluation for SaMD

- FDA Action Plan for Artificial Intelligence and Machine Learning (AI/ML) Software as a Medical Device

Engaging with FDA for Feedback on Medical Software Development (e.g., 513(g) and Pre-Submission)