Category: Regulations & Standards

FDA Drafts Early Warning System for Potential Device Safety Issues

The FDA has announced the agency’s new Draft Guidance, which outlines a system for alerting the public to possible safety issues with medical devices before the agency has investigated whether a serious risk actually exists. The agency is accepting comments in advance of issuing a final version of the guidance, which can be submitted until February 29 on its Regulations webpage.

Read More
Loading