North Texas Biomedical Association




AAMI Webinar: The Medical Device Data System Rule: Are You in Compliance?

  • 01 Jun 2011
  • 10:00 AM - 11:29 AM

On February 15, 2011, the United States Food and Drug Administration (FDA) issued a final rule on medical device data systems (MDDS).  An MDDS is a hardware or software product that transfers, stores, or converts device data, and the MDDS rule reclassifies these products as Class I, or low-risk, devices.    

The rule requires healthcare facilities that create or modify an MDDS to comply with all the regulatory requirements of a medical device manufacturer.  As a Class I device, an MDDS is exempted from premarket review but is subjected to quality systems, design control, and risk analysis requirements. The FDA expects all MDDS manufacturers, including hospitals, to create a quality system to ensure that they can consistently produce a safe and effective device and to establish a compliant medical device reporting (MDR) system by February 18, 2012.

The new rule raises many questions for healthcare facilities, such as: what products do I register and list with FDA?  Who is responsible?  Do I need to hire regulatory consultants?

To address what the new rule means for healthcare facilities and to answer questions about this new ruling, two expert speakers from the Center for Devices and Radiological Health, FDA will speak on an AAMI webinar on June 1, 2011, from 11:00-12:30 pm Eastern.


  • 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

NTBA North Texas Biomedical Association - Copyright 2011, All rights reserved.

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