A US Food and Drug Administration (FDA) spokeswoman told Focus on Wednesday that as part of global harmonization efforts around quality management systems, the agency is considering adding clauses ...
The Department of Health and Human Services (HHS) on Wednesday released the spring version of its unified agenda on proposed and final rulemakings, featuring a proposed rule on quality system ...
Fulfilling the required changes to FDA’s quality management system regulation (QMSR) ahead of February 2026’s compliance deadline is much ado about nothing for most companies, according to Kim ...
The U.S. Food and Drug Administration (FDA) published its long-awaited final rule to amend the Quality System Regulation’s (QSR’s) current good manufacturing practice (CGMP) requirements for medical ...
On February 2, 2024, the U.S. Food and Drug Administration (FDA) published a final rule 1 amending the device good manufacturing practice (GMP) requirements of the Quality System Regulation (QSR) 2 ...
Medical device manufacturers that want to avoid a long deficiency letter will want to pay close attention to FDA’s final cybersecurity guidance, updated in June 2025 (and again in February 2026).
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