CDRH New Update

The following new items were added to the CDRH web pages on September 12, 2018. Previous CDRH New items can be found on the CDRH New webpage.

• Waiver and Acknowledgment posted for Nicole R. Gonzales, M.D. (September 27, 2018 Neurological Devices Panel of the Medical Devices Advisory Committee meeting)
• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN180042 and DEN180044 added)
• Press Release: Statement from FDA Commissioner Scott Gottlieb, M.D., and Center for Devices and Radiological Health Director Jeff Shuren, M.D., J.D., on agency efforts to work with tech industry to spur innovation in digital health
• Press Release: FDA awards five grants to advance the development of pediatric medical devices
• Federal Register: Amending Premarket Regulations that Require Multiple Copies and Specify Paper Copies to be Allowed in Electronic Format