CDRH New Update

The following new items were added to the CDRH web pages on September 13, 2018. Previous CDRH New items can be found on the CDRH New webpage.

• Standards and Conformity Assessment Program
• Eliminating Routine FDA Re-Review of Third Party 510(k) Reviews
• Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff
• Recognition and Withdrawal of Voluntary Consensus Standards - Draft Guidance for Industry and Food and Drug Administration Staff
• 510(k) Third Party Review Program - Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations
• Consumer Information on: Hydrus® Microstent - P170034
• Mammography Facility Adverse Event and Action Report - September 13, 2018: Lakes Radiology II, Inc.
• Federal Register: 510(k) Third-Party Review Program
• Federal Register: Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices
• Federal Register: Recognition and Withdrawal of Voluntary Consensus Standards