From X-Rays to AI: Navigating US Regulations in Radiological Health
vi Regulatory Affairs Professionals Society (RAPS)
Author Acknowledgments
RAPS thanks the following subject matter experts for sharing their experience and knowledge and volun-
teering their time to contribute to From X-Rays to AI: Navigating US Regulations in Radiological Health.
Editors
Yuan Fang, PhD, MBA, PEng,
RAC-US
Divisional Vice President,
Global Strategic Regulatory
Abbott Laboratories Inc.
Jay Y. Vaishnav, PhD,
RAC-Devices
Director of Regulatory Affairs
RefleXion Medical
Authors
Gopal Abbineni, PhD, MS
Director, Regulatory Affairs
Bayer Pharmaceuticals
Esther Akinnagbe-Zusterzeel,
MS
Biomedical Engineer
Food and Drug Administration
Hortense Allison, MS, MBA,
RAC-US
Vice President and Head of
Regulatory Affairs
Bayer Pharmaceutical
Amarjeet S. Bhullar, PhD,
PSM
Medical Physicist
Food and Drug Administration
Kish Chakrabarti, PhD
Senior Expert Regulatory
Scientist (Retired)
Food and Drug Administration
Peter Coronado, MS, RAC-US
President and Principal
Consultant
Agile Regulatory Consulting
Jana G. Delfino, PhD
Deputy Division Director
Food and Drug Administration
Ruth Fischer, MHSA
Assistant Director for Guidance
Management (Retired)
Food and Drug Administration
Ninad A Gujar, PhD, MBA,
MS
Vice President
Samsung Healthcare
(NeuroLogica &Boston
Imaging)
Ningzhi Li, PhD, MS
Senior Reviewer
Food and Drug Administration
Catherine Lowe
Director/Consultant
LoweRiskQA Consulting Inc.
Sharon L. Murphy, MBA
Vice President Regulatory
Affairs
ZimmerBiomet
Yu-Wen Wang, PhD
Regulatory Affairs and Quality
Assurance Consultant
Terry Woods, PhD
Director, Standards and
Conformity Assessment
Program
Food and Drug Administration
Eriko Yoshimaru, PhD
Rongping Zeng, PhD
Food and Drug Administration