FDA QMSR

On 2 February 2024 FDA finalised the Quality Management System Regulation, amending 21 CFR Part 820 to incorporate ISO 13485:2016 by reference with a small set of US-specific additions (definitions, labelling/packaging controls, records). The rule takes effect 2 February 2026.

The QMSR makes ISO 13485 the operative QMS standard for US-marketed devices, materially aligning FDA with EU MDR/IVDR, MDSAP and other regimes. The Quality System Inspection Technique (QSIT) is being replaced; manufacturers should re-baseline procedures, training and internal-audit checklists before the effective date.