SMDA: Medical Device Reporting Requirements

March 1, 2008 | Aging Services Risk, Quality, & Safety Guidance

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The medical device reporting (MDR) regulations implementing the Safe Medical Devices Act (SMDA) went into effect in 1991 and were subsequently amended. The regulations present significant challenges for medical device “user facilities,” defined in the regulations as including, among others, nursing homes, skilled nursing facilities, and home care agencies.

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