Lexology February 6, 2024
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 devices. The final rule aims to align the U.S. regulations more closely with the International Organization for Standardization (ISO) standard 13485:2016, the international consensus standard for medical devices, by converging most of the quality management system (QMS) requirements used by FDA and regulatory authorities from other countries.
Medical device makers and importers have until February 2, 2026, to modify their quality systems to meet the now renamed QMS Regulations (QMSR). FDA’s newly QMS-aligned Quality System rules are summarized below.
FDA has just published a 101-page rule titled “Medical Devices; Quality System Regulation Amendments,”...
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