CDRH New Update

CDRHNew

Date: June 17, 2016

The following new items were added to the CDRH web pages on June 16, 2016. Previous CDRH New Items can be found on theCDRHNew Page.

• Announcing Final Guidance on Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and FDA Webinar on the Final Guidance - July 21, 2016
• Federal Register: Factors To Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
• Federal Register: Use of International Standard ISO 10993-1, `Biological evaluation of medical devices--Part 1: Evaluation and testing within a risk management process''; Guidance for Industry and Food and Drug Administration Staff; Availability