Seminar - Overview of FDA Requirements and Points to Consider During Prototype Development
Date: May 9, 2003
Time: 4:00 PM
Location: CAT, Room: 061
Speaker(s):
Sandy Weininger, Ph.D.
Details:
Dr. Weininger will give brief overviews of the FDA Regulatory Process and stress the importance of integrating safety into the design and development process. The Regulatory Process section will cover premarket and post-market activities, so that those developing new devices can do so rapidly and maximize safety and effectiveness.
Dr. Weininger will summarize how devices are classified, what requirements are applied to these classifications, and important activities such as hazard analysis and traceability analysis. He will touch briefly on the importance of a structured design and development process and risk management.
Biosketch:
Dr. Weininger received his BSEE and MS/BME from Drexel University. At the urging of his advisor, he continued to diversify his education across the street, where he earned a Ph.D. in Bioengineering from the University of Pennsylvania.
Dr. Weininger's areas of concentration are design and engineering of electronics and signal processing systems as applied to small physiological signals. His first job out of school was at Carter-Wallace, Inc., in Cranbury, NJ, where he was responsible for developing their biosensor program. He moved on to the US FDA, where he worked with a team of engineers to design and develop test methods to support the Apnea Monitor Performance Standard.
Currently, Dr. Weininger is a senior engineer with the Medical Electronics Branch of the Office of Science and Technology within the FDA's Center for Devices and Radiological Health. His responsibilities include supporting the regulatory process with technical consultants by leading industry-government partnership efforts to develop consensus standards to perform forensic engineering analyses and to develop test methods.
Directions:
CAT-061 is located in the basement of the CAT building, which is part of the LeBow Engineering Copmplex situated at the corner of 31st and Market Streets.
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