CDRH New Update

The following new items were added to the CDRH web pages on September 6, 2018. Previous CDRH New items can be found on the CDRH New webpage.

• Quality in 510(k) "Quik" Review Program Pilot
• Webinar - Quality in 510(k) "Quik" Review Program Pilot - October 10, 2018
• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN170078, DEN170090 and DEN180001 added)
• Federal Register: Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
• Federal Register: Request for Nominations for Voting Members on a Public Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee
• Federal Register: Request for Nominations on Public Advisory Panels of the Medical Devices Advisory Committee
• Federal Register: Request for Nominations of Voting Members on a Public Advisory Committee; National Mammography Quality Assurance Advisory Committee