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FDA Issues Technical Amendments to Align Device Regulations With the New QMSR, Effective February 2, 2026

Regulatory housekeeping with strategic implications: the FDA just updated 179 sections across 21 CFR to reflect the QMSR shift.

The FDA has published a new final rule updating references across 21 CFR Parts 801, 803, 812, 860, 862, 864, 866, 868, 872, 874, 876, 878, 880, 882, 886, 888, 890, and 892 to align the broader medical device regulatory framework with the previously finalized Quality Management System Regulation (QMSR).

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