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 ...

The FDA issued a final rule which continues efforts to promote consistency in the regulation of devices and provides timelier introduction of safe and effective high-quality devices for patients.

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 ...

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 ...

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To improve the overall safety and performance of medical devices, the United States FDA has proposed an amendment to the Code of Federal Regulations (CFR) for 21 CFR4 Part 820 of the current good ...

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The Pulse Report highlights AI-powered tracking and verification systems that can improve end-to-end visibility and help ...