MDDS Rule
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.