Medical devices; intent to initiate proceedings to establish effective dates of requirement for premarket approval for 31 class III preamendments devices--FDA. Advance notice of proposed rulemaking.

The Food and Drug Administration (FDA) is announcing its intent to initiate proceedings to establish the effective dates of the requirement for premarket approval for 31 class III preamendments devices. The devices subject to this notice were distributed commercially before May 28, 1976, or are devices that FDA has determined to be substantially equivalent to such devices. This notice of intent identifies the 31 class III preamendments devices to which FDA has assigned a high priority for the application of premarket approval requirements. FDA is taking this action under the Medical Device Amendments of 1976.