FDA Withdrawals Two Proposed Rules

FDA Withdrawals Two Proposed Rules

Today, the U.S. Food and Drug Administration (FDA) is announcing the withdrawal of two previously proposed rules: Laser Products; Proposed Amendment to Performance Standard (FDA-2011-N-0070) Electronic Submission of Labeling for Certain Home-Use Medical Devices (FDA-2016-N-2491) As part of the Administration’s regulatory reform initiative, we continue to conduct a review of existing proposed rules to determine whether proposals are outdated, unnecessary, or should be revised to reduce regulatory burden while allowing the FDA to achieve our public health mission.  The FDA believes these proposed rules are not candidates for final action because they need to be reconsidered based on public comments received and new information developed after the publication of the proposed rules.   If you have any questions, please contact the Center for Devices and Radiological Health’s Division of Industry and Consumer Education (DICE) at DICE@fda.hhs.gov, or by phone at 1-800-638-2041 or 301-796-7100. Food and Drug Administration Center for Devices and Radiological Health