About FDA

Laboratory of Medical Electronics

Laboratory leader: Al Taylor 301-796-2583 alford.taylor@fda.hhs.gov

There are an increasing number of medical devices that contain electronics and electrical components. Such devices are inherently complex and assessing them requires engineers to analyze the underlying mathematical and physical models that govern device operation, their hardware and software realizations, and even the physical characteristics of component parts. The mission of the Laboratory is to apply electrical engineering knowledge, including electronics, embedded systems, and systems engineering, to the regulation of electronic medical devices. 

The breadth of the engineering disciplines required to accomplish such a mission poses a significant challenge. Division engineers possess considerable expertise and maintain a suite of special-purpose engineering tools and laboratory facilities for performance assessment that have broad applicability to medical device electronics and embedded software.

Over the past two decades, advances in technology have brought many benefits to medical device users and patients. Technology trends have included an increase in computational power, decreased component size and reduced power consumption. More recently, many medical devices that health providers believe can benefit from an ability to share information have incorporated network technology, both wired and wireless, for accessing local area networks (LAN), wide area networks (WAN), and the Internet.. Such technology trends have enhanced device capabilities, allowing diagnostic and therapeutic equipment to be tailored to a range of specialized clinical situations, home care, and portable applications. The following key areas of research interests and support activities address challenges mentioned above:

  • Electrical safety hazard issues in medical electronic devices
  • Design and manufacturing of reliable medical electronic devices
  • Safety issues related to batteries used in medical electronic devices
  • Electronic instrumentation
  • Signal and data acquisition
  • Electromagnetic compatibility
  • Mathematical modeling and simulation of electronic systems
  • Forensic analysis
  • Educational outreach


Page Last Updated: 11/03/2014
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