CDRHNew
Date: July 11, 2016
The following new items were added to the CDRH web pages on July 8, 2016. Previous CDRH New Items can be found on the CDRHNew Page.
- Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Third-Party Review Under the Food and Drug Administration Modernization Act
- Federal Register: Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Ebola Zaire Virus; Availability
- Federal Register: Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Zika Virus; Availability
- Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices - Guidance for Industry and Food and Drug Administration Staff
- Summary Information for: Raindrop® Near Vision Inlay
- Federal Register: Use of Public Human Genetic Variant Databases To Support Clinical Validity for Next Generation Sequencing-Based In Vitro Diagnostics; Draft Guidance for Stakeholders and Food and Drug Administration Staff; Availability
- Federal Register: Use of Standards in the Food and Drug Administration's Regulatory Oversight of Next Generation Sequencing-Based In Vitro Diagnostics Used for Diagnosing Germline Diseases; Draft Guidance for Stakeholders and Food and Drug Administration Staff
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