CDRH New Update

The following new items were added to the CDRH web pages on April 16, 2018. Previous CDRH Newitems can be found on the CDRH New webpage.

• Federal Register: Policy Clarification and Premarket Notification Submissions for Ultrasonic Diathermy Devices; Guidance for Industry and Food and Drug Administration Staff; Availability
• Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination; Draft Guidance for Industry; Availability