The FDA published a draft guidance, “Breakthrough Devices Program Draft Guidance for Industry and Food and Drug Administration Staff,” on October 25, 2017. The full guidance is at the link provided. This supersedes the Expedited Access Pathway (EAP) introduced in 2015 and the Priority Review Program. The Breakthrough Devices Program is a voluntary program for...Read More
CSV Training Course
Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email firstname.lastname@example.org for more info.