The FDA published the guidance document “Refuse to Accept Policy for 510(k)s.” This supersedes the original, issued on August 4, 2015. This revision provides for additional requirements to better ensure substantive content, not just administrative elements that are checked in the initial 15 day refuse to accept initial review. Refuse to Accept Policy for 510(k)sRead 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 email@example.com for more info.