Under a new FDA rule, hospitals that are considered device manufacturers may be investigated by the agency for compliance, according to an Association for the Advancement of Medical Instrumentation news release.
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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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.
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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.
Related Articles on Device Safety:
New Material Will Create Smaller, Less Invasive Devices
Medical Device Lobby Calls for 6 Changes in Federal Policy
Congressman Criticizes FDA Delays for Device Approvals
