Dr. Weininger is a regulatory review expert in issues relating to connected medical systems and patient safety. He is retired from 35+ years of service at FDA where he was responsible for providing scientific and technical support for FDA’s regulatory programs, for serving as the focal point for Center activities addressing applications of computer and electronic technology in medical devices, including software and microprocessors and physiologic sensors, and for systems research and electrical engineering within the Office of Science and Engineering Laboratories (OSEL). Dr. Weininger helps transform industry expertise into practical regulatory policy and facilitates industry understanding and compliance of regulatory policy.
Dr. Weininger's current scientific and regulatory focus is the performance assessment of sensors and actuators for physiologic systems, and interactions within complex connected medical systems to assess safety. He works with standards development organizations, including UL, AAMI, IEC and ISO to construct both horizontal and vertical safety standards. He is actively involved in developing and delivering courses on achieving safety in medical devices using systems engineering principles. He is member of AAMI/UL 2800 – Interoperable Systems, AAMI Interoperability Work Group, past chair of the ASTM Pulse Oximeter Committee and FDA’s liaison to IEC TC 62 and SC 62A, committees responsible for safety of electromedical equipment, and ISO TC 121/SC3 JWG10 – oximeters. Dr. Weininger works with academic partners to develop methods for the evaluation of interoperable systems.
Dr. Weininger received his BSEE and MS/BME from Drexel University focusing on the properties of the electrode-tissue interface and his Ph.D. in Bioengineering from the University of Pennsylvania, where he specialized in signal processing and control systems as applied to physiologic signals. He worked for Carter-Wallace, Inc., in Cranbury, NJ, where he was responsible for setting up and developing their biosensor research program. He moved to the US FDA/Center for Devices and Radiological Health (CDRH), where he worked with a team of engineers to design and develop the Apnea Monitor Performance Standard and supporting test methods and was the principal engineer and developer for NIH Fox trial recording system. Currently, Dr. Weininger is a senior engineer with the Division of Biomedical Physics of the OSEL within the FDA's CDRH. Dr. Weininger's areas of concentration are design and engineering of electronics and signal processing systems as applied to small physiological signals. His responsibilities include supporting the regulatory process with technical consults, leadings industry-government partnership efforts to develop consensus standards, performing forensic engineering analyses, and developing test methods. He has extensive working knowledge of the IEC 60601 family and ISO 14971 medical device standards.
Dr. Weininger’s work has evolved from working on safety and performance assessment of single devices (e.g., pulse oximeters) to horizontal aspects (e.g., IEC 60601-1-10 Safety and essential performance of closed loop physiologic controllers) to properties of systems (e.g. UL2800, AAMI F2700 series). Dr. Weininger’s initial work at FDA was on constructing the first FDA mandatory performance standard and its test method (i.e., for Infant Apnea Monitors). This work evolved into investigating the safety properties of noninvasive monitoring and closed loop control systems, which further broadened into safety of applications built from systems of interoperable medical devices.
Dr. Weininger is regularly requested to provide support for projects involving research, standards, and regulatory consultations in the areas of medical device interoperability, noninvasive monitoring, and electromedical system safety. He blends findings from each of the three approaches (research, standards development, regulatory consults) into the others as needed. He has participated in activities throughout the medical device lifecycle including inspections and establishment inspection report analysis, recalls, MDR analysis, and premarket reviews.
Dr. Weininger was the electrical safety gatekeeper at FDA within OSEL, responsible for managing review requests from other Offices.
Professional Experience
Current:
Independent system safety consultant
Co-chair ISO/IEC JWG on oximeters (currently managing ISO 80601-2-61 pulse oximeters, ISO 80601-2-85 cerebral oximeters, IEC 80601-2-71 fNIRS)
Co-chair AAMI Interoperability WG (currently managing AAMI 2700-1 – Device in an Integrated Clinical Environment - ICE, AAMI 2700-2-1 Forensic Data Loggers)
IEC TC 62/SC 62A – US national expert, WG41 (PEMS, PCLC), WG44 (fire, thermal)
1990 to 2025:
US Food & Drug Administration, Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, Division of Biomedical Physics
Duties included electrical safety gatekeeper, developing Regulatory Science Tools and providing expert support for research activities involving oximetry and interoperable systems, regulatory consults for electromedical safety, and development of standards.
