Medical Device Tracking

The FDA requires manufacturers, hospitals, nursing homes, home health agencies, and other organizations that implant or distribute medical devices to collect information about certain medical devices used in patient care so that the device can be promptly identified and recalled if it presents a serious risk to patients' health. MDT regulations extend from manufacturing facilities to the distributor networks, which can include healthcare providers, and, ultimately, to patients so that patients using the device can be identified if necessary.

MDT regulations originate from the Safe Medical Devices Act of 1993 (SMDA), which was further amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). As outlined by MDT regulations, healthcare facilities typically fall under the tracking requirements that apply to final distributors and multiple distributors. (U.S. FDA "Medical Device Tracking") The organization needs to designate an individual or department, such as risk management, that is responsible for ensuring compliance.

As established by SMDA in 1993 and modified by FDAMA in 1997, FDA has discretion to regulate tracking of medical devices, including defining exactly which devices will be tracked. Currently, FDA orders manufacturers of certain types of class III or high-risk class II devices to track their devices after making a determination that the device is one that meets at least one of the following criteria (U.S. FDA "Medical Device Tracking"):

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