In the Federal Register of February 15, 2011(76 FR 8637), the FDA issued a final rule to reclassify MDDS from Class III (subject to premarket approval) to Class I (subject to general controls).
Devices that were not in commercial distribution prior to May 28, 1976, are generally referred to as post-amendment devices, and are classified by operation of law under section 513(f) of the Food Drug and Cosmetic Act (21 U.S.C. 360c(f)) as Class III devices. CDRH evaluates such post-amendment devices to establish the appropriate degree of regulatory controls needed to provide reasonable assurance of their safety and effectiveness. CDRH may decide to classify such a device as Class I (requiring general controls), Class II (requiring special controls), or Class III (requiring premarket approval).
Risks associated with MDDS include the potential for inaccurate, incomplete, or untimely data transfer, storage, conversion, or display of medical device data. In some cases, this can lead to incorrect patient diagnosis or treatment. Based on evaluation of these risks, the FDA has determined that general controls such as the Quality System Regulation (21 CFR part 820), will provide a reasonable assurance of safety and effectiveness. Therefore, special controls and premarket approval are not necessary.