The Electromagnetic and Electrical Safety Program in the FDA’s Center for Devices and Radiological Health (CDRH) conducts regulatory science research to help ensure patient access to innovative devices that are electromagnetically and electrically safe and effective. This is one of 20 research programs in CDRH’s Office of Science and Engineering Laboratories (OSEL).
Electromagnetic and Electrical Safety and Medical Devices
Electromagnetic and electrical safety affects an extraordinary number of medical devices because most devices use electrical power or use the electromagnetic spectrum from direct current to light. Although there are several mature technologies in these areas, new surgical techniques, such as those that use lasers and high intensity light inside the body, expose tissues that would otherwise never see light. Furthermore, wireless coexistence and electromagnetic compatibility standards for medical devices must be kept current, lest they become outdated in the face of the fast-changing electromagnetic environment in which we all live.
Regulatory science research is required in these areas to ensure existing standards adapt to changes and remain relevant. In addition, given continuous developments in electronics, optics and wireless communications, regulatory science research is needed to respond to changes in medical technology that endow medical devices with ever expanding sensing, data processing and communications capabilities.
Regulatory Science Gaps and Challenges
Major regulatory science gaps and challenges that drive the Electromagnetic and Electrical Safety Program are:
- Insufficient knowledge of the 5G performance characteristics necessary to ensure the safe operation of 5G-enabled medical devices.
- Inconsistent and burdensome application of IEC 60601-1.
- Poor quantification of the energy absorption related risk, stemming from radio frequency exposures and the increasing presence of implants in the body under rapidly evolving MR coil technologies and implant scanning scenarios.
- Insufficient knowledge and lack of standards for laser and optical radiation maximum permissible exposure (MPE) for tissues other than ocular and skin.
- Limited use of present medical device EMC standards in radiofrequency sources employed by 5G wireless communications.
The Electromagnetic and Electrical Safety Program is intended to fill these knowledge gaps by studying the safe use of electrical and non-ionizing electromagnetic energy in medical devices as well as developing less burdensome test methods for standards or evaluating known technologies in new environments.
Electromagnetic and Electrical Safety Program Activities
The Electromagnetic and Electrical Safety Program focuses on regulatory science research in these areas:
- Wireless Technology. For example, 5G mobile communication evaluation frameworks, and methods for wireless coexistence of 5G and of 802.11ax testing.
- Medical Device Electrical Safety. For example, test methods and criteria adequate for smart battery electrostatic discharge (ESD) testing, and simulation models to predict the long-term battery performance.
- Magnetic Resonance Imaging (MRI) Safety and Effectiveness. For example, computational electromagnetic models for clinical scenarios involving thermal risk, and blood flow phantoms for Arterial spin labeling (ASL) determination.
- Laser and Optical Radiation Safety (LORS). For example, test protocols and database for laser and optical radiation safety evaluation, and test methodologies for optical and laser radiation safety evaluation.
- Electromagnetic Compatibility (EMC). For example, existing medical device EMC standards do not cover high frequencies, such as those used by 5G above 2.7 GHz, nor do they cover low frequencies, such as those used by security scanners and wireless power transfer below 150 kHz.
For more information, email OSEL_electromagneticelectricalsafety@fda.hhs.gov