21 CFR Part 820
Also called FDA Quality Management System Regulation, QMSR
21 CFR Part 820 is the US FDA regulation for medical device quality systems. Under the Quality Management System Regulation (QMSR), effective in 2026, it is aligned with ISO 13485; design controls, document and change control, and the records behind them still apply.
For a medical device company, PLM is where design controls and change control live: design inputs and outputs, reviews, approvals and the trail behind every change. Many teams still call the design record the Design History File; confirm the current terms with your regulatory team.
A connected system makes the records an output of normal work instead of a scramble before an inspection.
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Last reviewed November 2026 by Element Consulting
