Withdrawal of the Laser Products; Proposed Amendment to Performance Standard and the Electronic Submission of Labeling for Certain Home-Use Medical Devices

Resumo

The Food and Drug Administration (FDA, Agency, we) is announcing the withdrawal of two proposed rules that published in the Federal Register. These proposed rules are not currently considered viable candidates for final action. FDA is taking this action because these proposed rules need to be reconsidered based on public comments received and new information developed after the publication of the proposed rules.