From X-Rays to AI: Navigating US Regulations in Radiological Health
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Table of Contents
Chapter 1 Regulatory Oversight of Radiological Health and Imaging Devices................................... 1
Eriko Yoshimaru, PhD
Chapter 2 Diagnostic X-Ray Imaging. ...............................................................................................15
Yu-Wen Wang, PhD, Sharon Murphy, MBA, Esther Akinnagbe-Zusterzeel, MS
Chapter 3 Magnetic Resonance Imaging Systems.............................................................................. 39
Jana G. Delfino, PhD Ningzhi Li, PhD Rongping Zeng PhD Terry Woods, PhD
Chatper 4 Mammography in the US: The Mammography Quality Standards Act and Beyond......... 57
Kish Chakrabarti, PhD, FAAPM Ruth Fischer, MHSA Jay Vaishnav, PhD, RAC
Chapter 5 Diagnostic Ultrasound Systems. ........................................................................................69
Yu-Wen Wang, PhD Ninad Gujar, PhD, MBA Yuan Fang, PhD, MBA, PEng, RAC-US
Chapter 6 Radiation Therapy and Nuclear Medicine: An Overview of Current Trends..................... 79
Peter Coronado, MS, RAC Jay Vaishnav, PhD, RAC Amarjeet Bhullar, PhD, PSM
Chapter 7 The Regulation of Software in the Radiological Health Space. .........................................97
Catherine Lowe Qin Li, PhD
Chapter 8 Artificial Intelligence-based Software. .............................................................................113
Gopal Abbineni, MS, PhD Hortense Allison, MS, MBA
Tables
Table 1-1. List of CDRH Review Offices............................................................................................. 2
Table 1-2. Summary of Premarket Submission Types........................................................................... 5
Table 1-3. Fiscal Year 2022 MDUFA Cohorts by CDRH’s OHTs. .....................................................7
Table 1-4. Record and Reporting Requirements by Product – 21 CFR §1002.1 (Table 1). ...............10
Table 2-1. Applicability of International Electrotechnical Commission (IEC) Standards to
Specific Medical Device Classifications. ............................................................................17
Table 2-2. Electronic Product Radiation Control (EPRC) Requirements That Would Not be
Deemed to be Met Based Solely on Conformity to International Electrotechnical
Commission (IEC) standards. ...........................................................................................18
Table 2-3. General Comparison Between Film-Based Radiography, Computed Radiography (CR),
and Direct Digital Radiography (DDR). ...........................................................................23
iii
Table of Contents
Chapter 1 Regulatory Oversight of Radiological Health and Imaging Devices................................... 1
Eriko Yoshimaru, PhD
Chapter 2 Diagnostic X-Ray Imaging. ...............................................................................................15
Yu-Wen Wang, PhD, Sharon Murphy, MBA, Esther Akinnagbe-Zusterzeel, MS
Chapter 3 Magnetic Resonance Imaging Systems.............................................................................. 39
Jana G. Delfino, PhD Ningzhi Li, PhD Rongping Zeng PhD Terry Woods, PhD
Chatper 4 Mammography in the US: The Mammography Quality Standards Act and Beyond......... 57
Kish Chakrabarti, PhD, FAAPM Ruth Fischer, MHSA Jay Vaishnav, PhD, RAC
Chapter 5 Diagnostic Ultrasound Systems. ........................................................................................69
Yu-Wen Wang, PhD Ninad Gujar, PhD, MBA Yuan Fang, PhD, MBA, PEng, RAC-US
Chapter 6 Radiation Therapy and Nuclear Medicine: An Overview of Current Trends..................... 79
Peter Coronado, MS, RAC Jay Vaishnav, PhD, RAC Amarjeet Bhullar, PhD, PSM
Chapter 7 The Regulation of Software in the Radiological Health Space. .........................................97
Catherine Lowe Qin Li, PhD
Chapter 8 Artificial Intelligence-based Software. .............................................................................113
Gopal Abbineni, MS, PhD Hortense Allison, MS, MBA
Tables
Table 1-1. List of CDRH Review Offices............................................................................................. 2
Table 1-2. Summary of Premarket Submission Types........................................................................... 5
Table 1-3. Fiscal Year 2022 MDUFA Cohorts by CDRH’s OHTs. .....................................................7
Table 1-4. Record and Reporting Requirements by Product – 21 CFR §1002.1 (Table 1). ...............10
Table 2-1. Applicability of International Electrotechnical Commission (IEC) Standards to
Specific Medical Device Classifications. ............................................................................17
Table 2-2. Electronic Product Radiation Control (EPRC) Requirements That Would Not be
Deemed to be Met Based Solely on Conformity to International Electrotechnical
Commission (IEC) standards. ...........................................................................................18
Table 2-3. General Comparison Between Film-Based Radiography, Computed Radiography (CR),
and Direct Digital Radiography (DDR). ...........................................................................23