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U.S. Department of Health and Human Services

About FDA

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FY 2001 Electronics/Electrical Engineering/Software Engineering/System Engineering

Electronic, software, and systems engineering concerns lie at the heart of the problems encountered with most of the sophisticated new medical devices regulated by the Agency. A critical core of expertise has been developed in each of these areas to address Center needs.

The DECS program provides a broad range of technical assistance in these areas to ORA and to all Center components. In addition, it includes active efforts in standards development, tool development and monitoring, demonstration projects, and training/industry outreach. Engineers in this program investigate and analyze issues involving the design of complex medical devices, focusing on both the adequacy of designs themselves and on the adequacy of the manufacturer's design and manufacturing processes.

In the premarket area, DECS engineers review and analyze information submitted by the manufacturer, including product descriptions, design documentation, and engineering data, to determine whether the firm's engineering and clinical judgments concerning safety and effectiveness are reasonable. DECS engineers participate in plant inspections when their specialized expertise is requested by ORA. They review and analyze information submitted by the manufacturer, including quality manuals, procedures, work instructions, and records, to assess the degree to which the manufacturer's quality system conforms to FDA requirements and the degree to which a quality system is being followed in practice. They also plan and execute special laboratory investigations in order to either confirm a performance claim made by a manufacturer or to determine the root cause of a medical device failure.

Electronics/Electrical Engineering in Medical Devices

Key words: electrical engineering, electronics

OST provides technical support for issues involving the use of electronics in medical devices. The areas of specific concentration include the following:

  • Sensors, Analog and Digital Signal Processing, Data Acquisition
  • Microprocessor and Digital System Design
  • Batteries, Power Electronics, Power Quality
  • MEMS Devices, Microcircuits
  • Electrical Safety, Fire Safety
  • Electronic Design and Manufacturing Processes

The support that OST provides in this area of consists of the following:

  • Policy Interpretation and Implementation
  • Technical Assistance to ORA/OC/ODE
  • Standards Development and Insertion
  • Tools Development/Monitoring of New Tools
  • Demonstration Projects
  • Training/Industry Outreach.

Engineers in this program area investigate and analyze issues involving the design of electronic medical devices, focusing on both the adequacy of the designs themselves and on the adequacy of the manufacturer’s design and manufacturing processes.

In the premarket area, OST engineers review and analyze information submitted by the manufacturer, including product descriptions, design documentation, and engineering data, to determine whether the firm's engineering and clinical judgments concerning safety and effectiveness are reasonable. In FY 2001, OST engineers performed 37 engineering reviews of premarket submissions.

In support of FDA field enforcement activities, OST engineers participate in plant inspections when their specialized expertise is requested by ORA. They review and analyze information submitted by the manufacturer, including quality manuals, procedures, work instructions, and records, to assess the degree to which the manufacturer’s quality system conforms to FDA requirements and the degree to which to a quality system is being followed in practice. They also plan and execute special laboratory investigations, in support of regulatory activities, in order to either confirm a performance claim made by a manufacturer or to determine the root cause of a medical device failure. In FY 2001, OST engineers performed substantive analysis and/or investigations in 10 compliance cases.

OST engineers develop laboratory test methods to facilitate the regulatory review process. They accomplish this by providing objective and repeatable approaches to measuring aspects of device performance that bear on safety and/or effectiveness in addition to developing custom instrumentation to support other FDA internal research activities.

OST engineers consult with other government agencies, standards-setting organizations, university researchers, and professional societies on matters related to the design and manufacturer of medical electronics.

OST staff members are involved in an ongoing project to upgrade the instrumentation in the CDRH X-ray calibration laboratory. They have developed a new architecture, involving a network of microprocessor-based controllers, which has significant reliability and performance advantages over the existing system. In FY 2001, the operation of the first of the new controllers was validated.

Software Use in Medical Devices

Key words: software, software safety, software engineering

OST provides technical support for issues involving the use of software in medical devices. The discipline of software engineering includes the following four broad areas:

  • software safety and software risk management;
  • software requirements, analysis, and definitions;
  • software design methods; and
  • software verification, validation, and testing.

The support that OST provides in the area of software engineering consists of the following:

  • policy interpretation and implementation;
  • technical assistance to ORA/OC/ODE;
  • standards development and insertion;
  • tools development/monitoring of new tools;
  • demonstration projects; and
  • training/industry outreach.

Engineers in this program area investigate and analyze issues involving the design of software use in or as medical devices, focusing both on the adequacy of designs themselves and also on the adequacy of the manufacturer’s design processes. They review and analyze information submitted by the manufacturer, including product descriptions, specifications and requirements, design documentation, hazard analysis, and verification, validation and testing information, to assess the safety and effectiveness of the software. In FY 2001, OST engineers performed 103 software reviews of premarket submissions.

In support of enforcement activities, engineers in this program area participate in plant inspections when their specialized software engineering expertise is requested by ORA. In this role, they act as national software experts for ORA. They also review and analyze information submitted by the manufacturer, including quality manuals, procedures, and records, to assess the degree to which the manufacturer’s quality system conforms to FDA requirements, and the degree to which to a quality system is being followed in practice. OST software engineers have provided extensive support to other FDA Centers (for example, helping CBER to manage complex issues involving blood bank software by reviewing seven premarket application in FY 2001).

OST engineers develop laboratory projects to evaluate tools that can be used to facilitate the regulatory review process by providing objective and repeatable approaches to measuring aspects of software performance that bear on safety and/or effectiveness. They are also working with Agency senior staff to develop policy related to Part 11 - Electronic Records and Signatures.

OST engineers consult with other government agencies, standards-setting organizations, university researchers, and professional societies on matters related to the design and manufacturer of medical electronics. OST engineers conduct outreach programs to help regulated industry and academia understand FDA policy related to software.

An OST software engineer represents FDA on both the DARPA High-Confidence System Workgroup and the National Science Foundation's High-Confidence Software and Systems initiative. These government-wide groups fund the research of engineering methods for safer, more secure and more reliable software. FDA provides public health concerns in this forum. This engineering input fosters improvement in the state-of-the-software-art, which provides medical device manufacturers with the tools necessary to produce safe and effective software.

Medical Device Systems

Key words: quality systems, risk management, reliability, systems engineering

Medical devices that incorporate electronics and/or software are inherently complex devices. Engineers who develop and analyze these devices must be able to skillfully peel back many layers of abstraction from the underlying mathematical models that govern device operation, to their hardware and software realizations, and down to the physical characteristics of component parts.

Historically, many device problems arise at the intersections of hardware and software, the user, the manufacturing process and the use environment. A broad range of analytical tools are available to systems engineering specialists to help them identify such problems and take reasonable steps to prevent or limit the problems and/or mitigate the consequences.

Different analytical techniques are applicable at different stages of the device life cycle. These techniques permit systems engineers to manage the complexity of the design by providing a structured approach to dealing with different aspects of the design. The term system effectiveness has been used in industry to describe the range of concerns addressed by these analytical techniques, including the following:

  • reliability
  • dependability
  • maintainability
  • manufacturability
  • testability
  • serviceability
  • capability
  • safety engineering and risk management
  • metrology

OST engineers have extensive practical experience in all of these areas of concern. In the area of reliability engineering, for example, expertise exists in the analytical techniques used to characterize system reliability. There is also expertise in component-level failure modes and control methods. For example, OST investigated damage due to electrostatic discharge in semiconductors and integrated circuits and failures of multilayer ceramic packages due to metal migration through microscopic cracks in the ceramic dielectric material.

In the area of electronic packaging, OST addressed issues of thermal management and susceptibility of circuits to environmental influences such as temperature and humidity extremes, water and chemical ingress, shock and vibration, and radiation.

Due to the enormous breadth of technologies employed in medical devices, it is impossible to cover all of these areas in depth. Instead, OST focuses on understanding the principles of system effectiveness. In many cases, OST relies heavily on external subject matter experts from industry, academia, and other Government laboratories, particularly, NASA, NIST, and the Department of Energy National Laboratories. OST's role is to analyze the device issue in order to understand the nature of the problem, seek out the appropriate technical expertise, and interpret the information obtained in the context of the clinical application and the FDA regulatory environment.

With the implementation of the Total Product Life Cycle (TPLC) approach to regulating medical devices, the concept of system effectiveness takes on a whole new and significantly more meaningful role for the Center. OST engineers have long advocated a TPLC approach to medical device design. In recent years, OST's systems engineering approaches have been applied to numerous CDRH internal regulatory processes through invited participation in re-engineering teams and related management initiatives.

OST provided consultation to various field investigators on a variety of quality system issues involving design controls, corrective and preventive actions, and calibration of test and measuring equipment. The focus of OST's contribution in these cases is reconciling the general requirements of the quality system regulation with the specific practices of the electronics industry.