FDA Quality System Inspection Focus Shifts To CAPA Compliance
This article was originally published in The Gray Sheet
Executive Summary
FDA plans to emphasize compliance with corrective and preventive action (CAPA) requirements as it implements the nascent medical device quality system inspection technique (QSIT).
You may also be interested in...
Management Deficiencies Top Quality System Problem Areas - QSIT Pilot
Management controls are emerging as a new area of quality system problems for device manufacturers, according to results from FDA's quality systems inspections technique (QSIT) pilot.
MoCRA’s Adulteration Ambiguity And FDA’s New Cosmetic Recall Authority: Attorney Weighs In
The US FDA should use guidance or rulemaking to clarify MoCRA provisions related to adulteration, Amin Wasserman Gurnani attorney Angela Diesch suggested at the Independent Beauty Association’s Cosmetics Convergence Spring Symposium. Attendees also sought her take on whether the agency’s new recall authority is likely to spell an increase in cosmetic product recalls.
Medtronic Launches Remote Live-Stream Surgery, New AI Capabilities
Medtronic will launch a new feature that allows for live streaming of surgical procedures in more than 20 countries and the addition of 14 AI-driven algorithms to enhance surgical workflow.