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# Proposed Rule on QSR Harmonization Due by 4/19: Maisel
- URL: https://www.fdaweb.com/proposed-rule-on-qsr-harmonization-due-by-4-19-maisel/
- Published: 2018-09-27T12:00:00.000Z
- Updated: 2026-09-15T00:34:27.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142467

CDRH chief medical officer **William Maisel** has reaffirmed the agency’s intention to modernize its Quality System regulation (QSR) for medical devices by harmonizing and “supplanting” existing requirements with the specifications in ISO 13485:2016\. The agency noted its desire to harmonize the QSR in a Unified Agenda [notice](https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201804&RIN=0910-AH99&ref=fdaweb.com) earlier this year. “The revisions are intended to reduce compliance and recordkeeping burdens on device manufacturers by harmonizing domestic and international requirements,” the notice said. “The revisions will also modernize the regulation.”

Addressing a session at the MedTech Conference 9/25 in Philadelphia, Maisel said industry should expect a notice of proposed rulemaking by 4/2019 ([see slide presentation](http://www.fdaweb.com/download.php?file=Maisel%5FInspections%5FMedTech%5F2018..pdf)). He said the agency’s approach to harmonizing the QSR will be consistent with and complement the approach of the [Medical Device Single Audit Program](https://www.fda.gov/MedicalDevices/InternationalPrograms/MDSAPPilot/default.htm?ref=fdaweb.com).

  
Global consulting firm Oriel has said in a [post](https://www.orielstat.com/blog/fda-move-toward-13485/?ref=fdaweb.com) that it is not likely FDA will throw out the QSR entirely. “FDA may incorporate all major components of ISO 13485:2016 into a completely new version of 21 CFR Part 820, with addendums to suit the specific requirements of U.S. law, the group said. Also, the group noted the time needed to implement this massive undertaking. “Hundreds of guidance documents will need to be amended,” it said. “The FDA quality system inspection process (QSIT) will need to be overhauled. A public comment period lasting months or years will have to occur, and the agency will have to conduct an economic impact analysis. And let’s not forget that undoing regulations is often as difficult as implementing them.”