FDA published a final rule in February regulating MDDS products, which transfer, store, convert or display medical device data. The rule states that any entity, including hospitals, that creates or significantly modifies an MDDS is considered a manufacturer and must adopt a quality system.
The MDDS rule emerged in recognition that software can be considered a medical device. Hospitals have until Feb. 14, 2012, to implement a quality system. An FDA official clarified, however, that electronic health record systems are not considered MDDS.
Read the news release about the new medical device data system regulation.
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