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# Proposal to Harmonize Device QSR with ISO 13485
- URL: https://www.fdaweb.com/proposal-to-harmonize-device-qsr-with-iso-13485/
- Published: 2022-02-23T12:00:00.000Z
- Updated: 2026-09-14T17:33:47.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5151217

*Federal Register* notice: FDA is publishing a proposed rule to amend medical device current GMP requirements of the Quality System Regulation to align more closely with the International Organization for Standardization’s 13485\. It is also proposing additional requirements to clarify device GMP requirements for combination products. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2022-02-23/pdf/2022-03227.pdf?ref=fdaweb.com).