DESIGN CONTROL INSPECTION SCOPE TO BE CLARIFIED BY FDA IN UPCOMING POLICY STATEMENT; FIRMS WILL CHOOSE WHICH PRODUCTS UNDERGO DESIGN CONTROL AUDITS
This article was originally published in The Gray Sheet
Executive Summary
FDA design control inspections in the first, "transition" year of design control requirements will address design modifications to currently marketed products, new designs reaching transfer to manufacturing, and products for which a premarket approval application, 510(k) or investigational device exemption request have been submitted to FDA, Greg O'Connell, a biomedical engineer in the Center for Devices and Radiological Health's Office of Compliance, said at the Association for the Advancement of Medical Instrumentation annual meeting June 10 in Washington, D.C.
You may also be interested in...
Roche Gets Adjuvant ALK+ Lung Cancer To Itself With Alecensa Approval
The US FDA cleared Roche’s supplemental approval request for ALK inhibitor Alecensa in ALK-positive non-small cell lung cancer following tumor resection.
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.