CDRH New Update

CDRHNew

Date: August 31, 2017

The following new item was added to the CDRH web pages on August 30, 2017. Previous items can be found on the CDRHNew Page.

• Webinar - Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices - October 10, 2017
• Presentation and Transcript added to Webinar - CDRH Final Guidance: Qualification of Medical Device Development Tools - August 24, 2017
• Information about the Use of Forced Air Thermal Regulating Systems - Letter to Health Care Providers
• Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices - Guidance for Industry and Food and Drug Administration Staff
• Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices - Draft Guidance for Industry and Food and Drug Administration Staff
• Federal Register: Policy Clarification and Premarket Notification (510(k)) Submissions for Ultrasonic Diathermy Devices
• Federal Register: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices