CDRHNew
Date: September 2, 2016
The following new items were added to the CDRH web pages on September 1, 2016. Previous CDRH New Items can be found on theCDRHNew Page.
- Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices - Guidance for Industry and Food and Drug Administration Staff
- Incorrect Assignment of Test Results Associated with Sciex Mass Spectrometers: FDA Safety Communication
- Federal Register: Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products; Public Hearing; Request for Comments
- Meeting Notice: October 5, 2016 Microbiology Devices Panel of the Medical Devices Advisory Committee
- Federal Register: Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
- Potential Risk of Severe Bleeding and Hematomas Associated with VASCU-GUARD Peripheral Vascular Patch – Letter to Health Care Providers
- Webinar - Final Guidance on Adaptive Designs for Medical Device Clinical Studies - September 22, 2016
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