WASHINGTON, Nov. 17 -- Food and Drug Administration has issued a notice called: Quality Management System Information for Certain Premarket Submission Reviews; Draft Guidance for Industry and Food and Drug Administration Staff; Availability.
The notice was published in the Federal Register on Nov. 17 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.
Summary: The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Quality Management System Information for Certain Premarket Submission Reviews." The medical device current good manufacturing practice (CGMP) requirements, previously in the quality system regulation (QS regulation) and now the qual...