CDRH New Update

CDRHNew

Date: January 17, 2017

The following new items were added to the CDRH web pages on January 13, 2017. Previous CDRH New Items can be found on the CDRHNew Page.

• Federal Register: Cardiovascular Devices; CFR Correction
• Emergency Use Authorization Amendment: Letter Granting EUA Amendment(s) for the Trioplex Real-time RT-PCR (CDC)
• Federal Register: Factors To Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions; Guidance for Investigational Device Exemption Sponsors, Sponsor-Investigators, and Food and Drug Administration Staff; Availability
• FUJIFILM Medical Systems, U.S.A., Inc. removes certain older duodenoscope models from clinical use: FDA Safety Communication
• Laboratory Developed Tests