FDA issued the draft guidance “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program” June 7, 2018. Note that there are a variety of types of Q-submissions and they do not need to be tied to a specific planned 510(k) or other premarket submission. Also note that they are not meant to...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.