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Thursday, April 7, 2011

Medical Device Regulation: An Overview from the FDA

I don't usually cover medical device related topics in this blog, but the recent MDDS final rule (pdf) from the FDA has potential impacts on Health IT solutions using separate  interface engines.  As interface enginers are commonly used with Health IT, and they  could under this rule be considered a Medical Device Data System, I thought this webinar might be of interest to my readers.

  -- Keith

The FDA is presenting on the Medical Device Regulation on an upcoming HIMSS Webinar (April 13th). You will need to register for this event (free to HIMSS members).  Thanks!

Medical Device Regulation: An Overview from the Food and Drug Administration
Date: 4/13/2011
4:00-5:00PM EDT
Cost: $0.00 for HIMSS members $79.00 for non-HIMSS members
The Food and Drug Administrations (FDA)'s Center for Devices and Radiological Health (CDRH) has the responsibility for assuring safety and effectiveness of medical devices in the United States.  The CDRH oversees medical devices by classifying them based on risk along with a number of oversight tools to promote health and reduce risk of harm to patients.  On February 15, 2011, the FDA published its final rule to reclassify Medical Device Data Systems (MDDS).  A Medical Device Data System is a new category of medical device that acts as a conduit for communication of electronic data obtained from other medical devices.  Learn more about the new rule and its implications for your organization from two key representatives of the Center for Devices and Radiological Health.
Learning Objectives: 
  • Explore the role of the Center for Devices and Radiological Health plays in the regulation of medical devices
  • Gain an understanding of risk-based oversight
  • Discuss the Final "Medical Device Data Systems" rule
  • Anthony D. Watson, BS, MS, MBA, Director, Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration 
  • Bakul Patel, MSEE, MBA, Policy Advisor, Officer of the Center Director, Center for Devices and Radiological Health, Food and Drug Administration
Continuing Education:
This webinar has been approved for up to 1.0 continuing education (CE) hours for use in fulfilling the continuing education requirements of the Certified Professional in Healthcare Information & Management Systems (CPHIMS)


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