> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# QSR Proposed Revisions Will Advance Harmonization: Post
- URL: https://www.fdaweb.com/qsr-proposed-revisions-will-advance-harmonization-post/
- Published: 2022-05-12T12:00:00.000Z
- Updated: 2026-09-14T17:44:28.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5151800

Pharmatech Associates managing director **Stephanie Gaulding** says proposed revisions to FDA’s Quality System Regulation for medical devices “is a significant step toward global harmonization and reduces the amount of U.S.-specific regulations for medical device manufacturers, especially relating to structure and requirements for a medical device quality management system.” In a *Med Device Online* [post](https://www.meddeviceonline.com/doc/cfr-s-new-terminology-country-specific-terms-for-medical-device-quality-0001?vm%5FtId=2412403&vm%5FnId=71786&user=af07de6f-3851-4b1a-b184-d350b10f9e44&gdpr=0&vm%5Falias=21%20CFR%20820%27s%20New%20Terminology%20%26amp;amp;%20Country-Specific%20Terms%20For%20Medical%20Device%20Quality&utm%5Fsource=mkt%5FMDOL&utm%5Fmedium=email&utm%5Fcampaign=MDOL%5F05-12-2022&utm%5Fterm=af07de6f-3851-4b1a-b184-d350b10f9e44&utm%5Fcontent=21%20CFR%20820%27s%20New%20Terminology%20%26amp;amp;%20Country-Specific%20Terms%20For%20Medical%20Device%20Quality&mkt%5Ftok=MDc1LU5WQy0wODYAAAGEV2%5FImrgBk1T5FnPbhiTwr27FCYYgbBGeUTDf17Ez2FuL%5FgdRhfV5zeN6jWH8TgDjVCHsfcVv-U4zROqqnppZHCEFl6IOPUfC2LGDCi1uVunV6Q), Gaulding reviews some of the changes in terminology that will still require U.S.-specific terms because either they are not included in the harmonized document or the definition in that document conflicts with FDA institutionalized terminology.

She also notes a “subtle” change in the regulation title from Quality Systems Regulation to Quality Management System Regulation. “While this seems insignificant,” she writes, “think about how many places this title may be listed. Given the one-year proposed transition period for the revised regulation, manufacturers will need to review in-house terminology against the proposed definitions and terminology to identify where changes are needed within their own quality management system infrastructure. For medical device manufacturers (including those who manufacture components that have never implemented ISO 13485:2016, more significant updates will be required to comply with the proposed Quality Management System Regulation.”

Gaulding says one significant change resulting from the proposed FDA revision would be replacing the Quality Systems Inspection Technique approach to medical device manufacturing facility inspections with a yet-to-be-developed document on inspectional approaches for medical device manufacturers.