Date: June 18, 2015
The following new items were added to the CDRH web pages on June 17, 2015. Previous CDRH New Items can be found on theCDRHNew Page.
- Federal Register: Agency Information Collection Activities; Proposed Collection; Submission for OMB Review; Guidance for Industry and FDA--Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Principle
- Federal Register: Content and Format of Abbreviated 510(k)s for Early Growth Response 1 Gene Fluorescence In-Situ Hybridization Test System for Specimen Characterization Devices; Guidance for Industry and Food and Drug Administration Staff; Availability
- Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions - Draft Guidance for Investigational Device Exemption Sponsors, Sponsor-Investigators, and Food and Drug Administration Staff
- Federal Register: Medical Device User Fee Amendments; Public Meeting; Request for Comments
- Consumer Information on: Misago Peripheral Stent System - P140002
- Public Workshop - Non-Microbial Biomarkers of Infection for In Vitro Diagnostic Device Use, October 16, 2015
- SynCardia Systems - TAH-t Companion 2 Driver System (C2) - Letter to Health Care Providers
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