CDRH New Update

The following new items were added to the CDRH web pages on September 28, 2018. Previous CDRH New items can be found on the CDRH New webpage. Class I Medical Device Recall: Pro-Med Instruments Recalls the DORO LUCENT Headrest Due to Possible Malfunction and Failure Class I Medical Device Recall: Ventana Medical Systems Recalls Multiple Detection Kits Due to Potential for False Negative Results Caused by Reagent Dispenser Issues Press Release: FDA authorizes first next generation sequencing-based test to detect very low levels of remaining cancer cells in patients with acute lymphoblastic leukemia or multiple myeloma Federal Register: The Special 510(k) Program; Draft Guidance for Industry and Food and Drug Administration Staff; Availability