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# FDA Updates Device Inspection Program Due to QMSR Move
- URL: https://www.fdaweb.com/fda-updates-device-inspection-program-due-to-qmsr-move/
- Published: 2026-01-30T12:00:00.000Z
- Updated: 2026-09-14T15:32:05.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5160576

On 2/2, FDA is discontinuing the use of its Quality System Inspection Technique for medical device inspections and will instead conduct inspections using the process described in the updated [*Inspection of Medical Device Manufacturers Compliance Program (CP 7382.850)*](https://links-2.govdelivery.com/CL0/https:%2F%2Fwww.fda.gov%2Fmedia%2F80195%2Fdownload%3Futm%5Fmedium=email%26utm%5Fsource=govdelivery/1/0101019c10418e33-93df3ba5-d0a3-4d72-8844-9c4c2fb0c133-000000/8H-HEGwGqr2FyumXUSxfUKQCgANvsU4QL17%5FldaclLc=442?ref=fdaweb.com). FDA will also no longer use *Inspection of Medical Device Manufacturers (CP 7382.845)* or *Medical Device PMA Preapproval and PMA Postmarket Inspections (CP 7383.001)*.

These actions are part of FDA’s move to implement the amendments to 21 CFR Part 820, the Quality Management System Regulation (QMSR), which is intended to align its regulatory framework with that used by other regulatory authorities to promote consistency in device regulation. Specifically, QMSR harmonizes U.S. medical device GMPs with ISO 13485, adding explicit requirements for risk-management activities.

While the agency has previously said it does not plan new compliance programs or inspection protocols solely because of QMSR, CDRH associate director for compliance and quality **Keisha Thomas** stressed last month ([see story](https://www.fdaweb.com/device-compliance-official-flags-quality-gaps-rising-enforcement/)) that FDA will place far greater emphasis on how firms make risk-based decisions across the total product life cycle.

“When you look at complaint handling, CAPA, and MDR issues — the underlying thread is a risk-management system that isn’t optimal,” she said. “That is going to be the focus under QMSR.” Thomas encouraged firms to ensure they are prepared for risk-management expectations embedded in ISO 13485:2016, now incorporated directly into FDA’s quality-system requirements.

Looking ahead to 2026, Thomas said CDRH will continue to expand its risk-based enforcement approach, using analytics and signal trending across both product categories and corporate structures. CDRH will also intensify scrutiny of unapproved or unlawfully marketed devices, an area she said now accounts for the majority of Warning Letters. In FY 2025, about 61% of device Warning Letters cited unapproved or improperly marketed products, down from about 70% in FY 2024.

CDRH will further focus enforcement on data integrity and data quality in clinical trials and submissions, which Thomas described as a “significant safety issue” when compromised.