CDRH New Update

The following new items were added to the CDRH web pages on June 6, 2018. Previous CDRH Newitems can be found on the CDRH New webpage. Class I Medical Device Recall: Maquet Datascope Corp./Getinge Group Recalls the CARDIOSAVE Hybrid Intra-aortic Balloon Pump due to Fluid Ingress that May Affect Device Operation and Interrupt or Delay Therapy Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program - Draft Guidance for Industry and Food and Drug Administration Staff Federal Register: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program; Draft Guidance for Industry and Food and Drug Administration Staff; Availability Federal Register: Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 049