Draft Guidance Details cGMP Info for PMAs, HDEs Under New QMSR

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Draft Guidance Details cGMP Info To Include in PMAs, HDEs Under New Quality Management System Reg

Dennis Tosh

November 5, 2025 at 11:03 AM EST

New draft guidance issued by the FDA outlines the agency’s expectations for the quality management system (QMS) information to be included in premarket approval (PMA) applications and humanitarian device exemption (HDE) applications under the agency’s new quality management system regulation (QMSR), which is scheduled to go into effect on Feb. 2, 2026. When finalized, the FDA... Read More

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Draft Guidance Details cGMP Info To Include in PMAs, HDEs Under New Quality Management System Reg

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