CDRH New Update

The following new items were added to the CDRH web pages on May 30, 2018. Previous CDRH Newitems can be found on the CDRH New webpage.

• Recommended Content and Format of Complete Test Reports for Non-Clinical Bench Performance Testing in Premarket Submissions - Draft Guidance for Industry and Food and Drug Administration Staff
• FDA Innovation Challenge: Devices to Prevent and Treat Opioid Use Disorder
• Webinar - FDA Innovation Challenge: Devices to Prevent and Treat Opioid Use Disorder - July 25, 2018
• Federal Register: Recommended Content and Format of Complete Test Reports for Non-Clinical Bench Performance Testing in Premarket Submissions
• Waiver documents posted for June 14, 2018 Anesthesiology and Respiratory Therapy Devices Panel meeting
• Press Release: As part of efforts to combat opioid crisis, FDA launches innovation challenge to spur development of medical devices ‒ including digital health and diagnostics ‒ that target pain, addiction and diversion
• Press Release: FDA approves first artificial iris