CDRH New Update

The following new items were added to the CDRH web pages on November 28, 2017. Previous CDRH New items can be found on the CDRH New webpage.

• The FDA Warns that Biotin May Interfere with Lab Tests: FDA Safety Communication
• Recommendations for Dual 510(k) and CLIA Waiver by Application Studies - Draft Guidance for Industry and Food and Drug Administration Staff
• Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices - Draft Guidance for Industry and Food and Drug Administration Staff
• Public Workshop - Weighing the Evidence: Variant Classification and Interpretation in Precision Oncology, January 29, 2018 
• Webinar - CLIA Waiver Applications Draft Guidance Documents - January 8, 2018
• Federal Register: Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments Waiver by Application Studies
• Federal Register: Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications for Manufacturers of In Vitro Diagnostic Devices 
• FDA Voice Blog: X-rays and Children: FDA Issues Guidance to Minimize Dose