CDRHNew
Date: August 14, 2014
The following new items were added to the CDRH web pages on August 13, 2014. Previous CDRH New Items can be found on the CDRHNew Page.
- De Novo Classification Process (Evaluation of Automatic Class III Designation) - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 189KB)
- Summary Information for: Exact Sciences Corp. Cologuard™
- Unique Device Identification System: Small Entity Compliance Guide - Guidance for Industry and Food and Drug Administration Staff (PDF - 518KB)
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