The Medical Device Data System Rule: Are You in Compliance?
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, Anthony Watson from the Center for Devices and Radiological Health, was the speaker for this AAMI webinar on June 1, 2011.
SPEAKER
- 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
WHO SHOULD PURCHASE
The webinar is designed for clinical technology managers, clinical and biomedical engineers, hospital IT staff, device risk managers, field support personnel, telecommunications implementers, system integrators, and healthcare provider organizations using MDDS.
WEBINAR CD
- Includes pdf of handout materials and webinar recording on CD
- $50 for webinar registrants
- $75 for non-registrants
- Online – Purchase this webinar online.
- Phone - 1-877-249-8226 or 240-646-7031 to order with a credit card.
- Fax - Select and download the order form and fax to 240-396-5781.
- Mail - Select and download the order form and mail with payment to:
MDDS Webinar CD Package - AAMI Publications
PO Box 0211
Annapolis Junction, MD 20701-0211
QUESTIONS?
For questions about ordering the CD, please contact AAMI publications at 1-877-249-82261 or 240-646-7031.