The following new items were added to the CDRH web pages on April 12, 2019. Previous CDRH Newitems can be found on the CDRH New webpage.
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN180060 added)
- The FDA Continues to Remind Facilities of the Importance of Following Duodenoscope Reprocessing Instructions: FDA Safety Communication
- Press Release: Statement from Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on continued efforts to assess duodenoscope contamination risk
- Press Release: Statement from Jeff Shuren, M.D., director of the Center for Devices and Radiological Health, on agency efforts to mitigate temporary shortage of pediatric breathing tubes due to recent closure of Illinois sterilization facility
- Federal Register: Anesthesiology Devices; Classification of the Ventilatory Electrical Impedance Tomograph
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