CDRH New Update

CDRHNew

Date: August 27, 2015

The following new items were added to the CDRH web pages on August 26, 2015. Previous CDRH New Items can be found on theCDRHNew Page.

• Class II Special Controls Guideline Document: Toxin Gene Amplification Assays for the Detection of Clostridium difficile - Guideline for Industry and Food and Drug Administration Staff
• Class I Medical Device Recall: Teleflex Medical, Hudson RCI Sheridan Sher-I-Bronch Endobronchial Tube - Connector May Crack or Separate