CDRHNew
Date: September 26, 2014
The following new items were added to the CDRH web pages on September 25, 2014. Previous CDRH New Items can be found on the CDRHNew Page.
- Content and Format for Abbreviated 510(k)s for Early Growth Response 1 (EGR1) Gene Fluorescence In-Situ Hybridization (FISH) Test System for Specimen Characterization Devices - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 135KB)
- Federal Register: Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
- Federal Register: Policy Clarification for Fluoroscopic Equipment Requirements; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
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