Medical Device Reporting

July 13, 2022 | Health System Risk Management

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Medical device reporting (MDR) is intended to help the U.S. Food and Drug Administration (FDA) identify medical device problems that pose a threat to public health and safety.

As established by the Safe Medical Devices Act (SMDA) in 1990 and modified by the FDA Modernization Act (FDAMA) in 1997, device user facilities, including healthcare organizations, are required to report certain adverse events involving medical devices to FDA and/or the device manufacturer. Device-related incidents that must be reported include deaths and serious injuries. These events must be reported to FDA as soon as practicable, but no later than 10 work days after the user facility becomes aware of a reportable event. These reports must be submitted in the following ways:

Failure to comply with FDA MDR requirements can result in substantial penalties for healthcare facilities. For example, failure to report or the submission of false or misleading information could subject the user facility to a civil injunction and/or criminal prosecution. In addition, failure to comply with regulations can result in civil money penalties of $15,000 for each violation, up to a maximum of $1 million for all violations adjudicated in a single proceeding. Civil money penalties can be imposed only if there has been a "significant or knowing departure" from the MDR requirements or if there is a "risk to public health." (21 CFR 803; FDA "Medical . . . User")

Under SMDA, three groups must report certain device-related adverse events and product problems to FDA (21 CFR 803):

Most healthcare organizations are considered to be device user facilities.

Distributors are required to maintain records of incidents but are not required to report incidents to FDA. (21...

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