The Medical Imaging and Diagnostics Program in the FDA’s Center for Devices and Radiological Health (CDRH) conducts regulatory science research to help ensure patient access to innovative, safe, and effective imaging and diagnostic medical devices. This is one of 20 research programs in CDRH’s Office of Science and Engineering Laboratories (OSEL).

Medical Imaging and Diagnostics and Medical Devices

Advances in medical imaging and diagnostics are resulting in new minimally invasive procedures and applications for medical devices in areas such as early breast cancer detection, brain imaging, retinal imaging, skin wound evaluation, modern endoscopy, diagnostic ultrasound imaging, and photoacoustic imaging.

The FDA has seen substantial growth in the number of submissions and technical consults related to medical imaging and diagnostics over the last few years; for example, OSEL has conducted about 600 consults on novel endoscopes for seven review branches in CDRH since 2013. However, because emerging devices are different from a functional standpoint than traditional imaging and diagnostic technologies, the technological and regulatory considerations are unique to these emerging platforms.

Despite its increased use, currently there are few or no regulatory tools specific for evaluating common risks associated with novel medical imaging and diagnostics devices.

Regulatory Science Gaps and Challenges

Major regulatory science gaps and challenges that drive the Medical Imaging and Diagnostics Program are:

• Insufficient guidance to evaluate existing and emerging technologies.
• Lack of modern, systematic, universal and least-burdensome test methods and technical guidance for hysteroscopes.
• Expensive and time-consuming clinical trials which involve additional radiation risk to the patient.
• Lack of universal testing methods to evaluate image quality that better reflects clinical diagnostic utility.
• Lack of simple imaging phantoms that work with new images (attenuation, sound speed, elastic modulus) and complex tissues.
• Lack of fully validated, standardized, hydrophone-spatial-averaging correction methods that work with most common diagnostic ultrasound applications.
• Lack of standardized performance test methods for emerging photoacoustic imaging.

The Medical Imaging and Diagnostics Program is intended to fill these knowledge gaps by fostering the development of predictable methods to evaluate existing and emerging technologies, least burdensome alternatives, and complements to clinical studies such as modeling and simulation, bench-top testing methods, and phantom development.

Medical Imaging and Diagnostics Program Activities

The Medical Imaging and Diagnostics Program focuses on regulatory science research in these areas:

• Advanced X-ray Imaging Methods
• Magnetic Resonance Imaging (MRI)
• Optical Spectroscopy and Spectral Imaging
• Endoscopy
• Ultrasound Imaging
• Ultrasound Imaging Safety
• Photoacoustic Imaging (PAI)
• Remote Vital Signs Detection
• Statistical Assessment

For more information, email [email protected]