CDRHNew
Date: June 16, 2016
The following new items were added to the CDRH web pages on June 15, 2016. Previous CDRH New Items can be found on theCDRHNew Page.
- Check the CDRH Customer Service Score
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150040 added)
- Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions - Draft Guidance for Industry and Food and Drug Administration Staff
- Federal Register: Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 042
- Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" - Guidance for Industry and Food and Drug Administration Staff
- Federal Register: Use of Symbols in Labeling
- Webinar - Draft Guidance: 'Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions' - July 11, 2016
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