FDA finalizes long-awaited Medical Device Data Systems rule

On February 15, 2011, the Food and Drug Administration (FDA or the Agency) issued a long-awaited final rule reclassifying Medical Device Data Systems (MDDS) as class I, 510(k)-exempt, medical devices. The final rule comes almost three years after the Agency's February 8, 2008, issuance of a proposed rule seeking to classify MDDS as class I, 510(k)-exempt.

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