Radiology Devices Branch
Division of Reproductive, Abdominal and Radiological Devices
Office of Device Evaluation
FDA Center for Devices and Radiological Health

Background:
B.A. (Mathematics), The Johns Hopkins University
M.D., Yale University School of Medicine
J.D., Fordham University School of Law
Previous Employment:
Yale University School of Medicine (1990-1999)
Cornell University Medical College (1999-2003)

Research / Regulatory Goals:
My research and regulatory duties are dedicated to accomplish FDA’s mission to protect and promote the health of all Americans by ensuring the safety and effectiveness of medical devices before they are used on the American public; committed to providing the best scientific information to patients and health care professionals and to making FDA a public health agency that is not only science-based, with its actions and regulatory decisions firmly grounded in science, but also science-led; stand behind the FDA values and vision; and committed to helping develop a gold-standard academic environment at FDA that promotes the values of accountability, civility, diversity, equity, excellence, integrity, transparency, and sound science.

Radiology (i.e., Imaging) devices have become an integral part of medical practice and are the dominant means of detection and diagnosis of numerous diseases and conditions.  Imaging devices are also widely used for treatment planning and therapy monitoring of benign and malignant disease.  Medical imaging drugs (i.e., contrast agents) are frequently used in clinical practice to enhance lesion detection and potentially improve diagnosis, treatment planning or therapy monitoring.  Medical imaging drugs include Gadolinium containing MRI contrast agents.  These agents are frequently used in clinical practice for “off-label” applications and at dosages of administration that may differ from those employed for approved applications.  Recent research has shown that Gadolinium-based contrast agents increase the risk for Nephrogenic Systemic Fibrosis (NSF) in patients with acute or chronic renal insufficiency.

As new technologies emerge, it is also important to re-evaluate and re-assess older technologies and re-define their role, if any, in current imaging practice.  Re-assessment of older technologies by FDA can include changes in device classification and regulation. Thermography devices are currently classified based on their intended use.  When used “adjunctively,” thermography devices are Class I devices.  When used in any non-adjunctive manner such as primary detection (e.g., screening for disease in asymptomatic patients), primary diagnosis, or therapy monitoring, thermography devices are Class III devices.  However, more than 15 years ago, FDA evaluation of thermography devices determined that thermography does not detect nor provide diagnoses of any conditions; rather, it is a method to detect skin surface temperature changes and should not be used alone as a diagnostic screening procedure.

Computer applications, e.g., computer-aided detection (CADe) and computer-aided diagnosis (CADx), are being developed to assist radiologists with the complex image interpretation task that requires analysis of vast quantities of image data and other information. A crucial component of the design and analysis of CADe and CADx devices is the human-device interaction.  These computer applications include the processing and analysis of images obtained without and/or with medical imaging drugs (i.e., contrast agents).  At the same time, as new technologies emerge, it is also important to re-evaluate and re-assess older technologies and re-define their role, if any, in current imaging practice. 

FDA fellows participating in this program can work on the following projects:

1. Off-Label use of Gadolinium Containing Contrast Agents with MRI Devices: Increased Risk of Nephrogenic Systemic Fibrosis (NSF)

Fellows participating in this research program will master the FDA regulation of medical imaging drugs, medical devices that can be used in conjunction with medical imaging drugs, and true drug-device (or device-drug) combination products.  The fellows will also master FDA regulation of so-called “off-label” use.  The project will include special emphasis on Gadolinium-based MRI contrast agents.  Future directions may include novel approaches to regulation of off-label use of medical imaging drugs and devices or combinations thereof.

2. Reclassification of Thermography Devices

Fellows participating in this research program will master the legal and regulatory requirements for device classification and re-classification.  This includes type of pre-marketing device submission (i.e., 510(k) and PMA), FDA determination of device safety and effectiveness, risk-benefit analysis, clinical significance of device use as part of the regulatory process, guidance documents, special controls, device recalls, labeling and labeling changes, precedence, etc.

3. Human Interaction and Optimal Design of Computer-Assisted Detection (CADe) and Computer-Assisted Diagnosis (CADx) Devices

Fellows participating in this research program will master the design and analysis of CADe and CADx devices with particular attention to human-device interaction.  The human-device interaction includes the user interface, interpretation strategies, incorporation into actual clinical practice paradigms, user knowledge of computer performance, strengths, and weaknesses and methods for continuous quality improvement.  The fellows will participate in developing novel methods for device assessment including the use of computer simulations of imaging findings.  Such design, development and assessment tools have direct application to testing of these devices for actual FDA pre-market submissions.

 

Selected Recent Publications:

1. Smith RC, Reinhold C, Lange RC, McCauley T, Kier R, McCarthy SM.  Fast Spin Echo MRI of the Female Pelvis Part I.  Use Of A Whole Volume Coil. Radiology 1992; 184:665-669.
2. Smith RC, Reinhold C, McCauley T, Lange RC, Constable RT, Kier R, McCarthy SM.  Part II Multicoil High Resolution Fast Spin Echo MR Imaging of the Female Pelvis.  Radiology 1992;.184:671-675.
3. Smith RC, Essenmacher KR, Rosenfield AT, Choe KA, Glickman M.  Acute Flank Pain: Comparison of non-contrast CT and IVU.  Radiology 1995; 194:789-794. 
4. Smith RC, Verga M, McCarthy SM, Rosenfield AT.  Diagnosis of Acute Flank Pain: Value of Unenhanced Helical CT  AJR 1996; 166:97-101. 
5. Smith RC, Verga M, Dalrymple NC, McCarthy SM, Rosenfield AT.  Acute Ureteral Obstruction: Value of Secondary Signs on Helical Unenhanced CT.  AJR 1996; 167:1109-1113. 
6. Choe KA, Smith RC, Wilkens K, Constable RT.  Motion Artifact on T2-Weighted Fast Spin Echo Images of the Liver: Effect on Image Contrast and Reduction of Artifact Using Respiratory Triggering.  JMRI 1997; 7:298-302.
7. Dalrymple NC, Verga M, Anderson KR, Bove P, Covey A, Rosenfield AT, Smith RC.  The Value of Unenhanced Helical CT in the Management of Patients with Acute Flank Pain.  Journal of Urology 1997; 159:735-740.
8. Smith RC, Lange RC.  Understanding Magnetic Resonance Imaging.  CRC Press, Boca Raton, FL, November,1997.
9. Lee C, Smith RC, The clinical utility of magnetic resonance imaging of the breast in the evaluation of the problem mammogram.  AJR 1999; 173:1322-1329. 
10. Brown J, Smith RC, Lee C.  Incidental enhancing lesions found on magnetic resonance imaging of the breast. AJR 2001;176:1249-1254.

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