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# FDA Shifts to Risk-Based Device Inspections under QMSR
- URL: https://www.fdaweb.com/fda-shifts-to-risk-based-device-inspections-under-qmsr/
- Published: 2026-02-13T12:00:00.000Z
- Updated: 2026-09-14T13:33:50.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5160665

As part of FDA’s recent implementation of the Quality Management System Regulation (QMSR), a new risk-based inspection model is set to change medical device oversight. The updated framework is detailed in the agency’s revised *Inspection of Medical Device Manufacturers Compliance Program Manual (CP-7382.850)* and applies to all quality system inspections — including preapproval inspections, routine surveillance, compliance follow-ups and for-cause investigations.

“Under the new process, consistent with the QMSR’s focus on risk management, investigators will begin by reviewing a company’s risk management file to identify product-specific risks, according to device regulatory experts writing in an *FDALawBlog* [post](https://www.thefdalawblog.com/2026/02/understanding-fdas-risk-based-inspection-model-under-qmsr/?utm%5Fsource=rss&utm%5Fmedium=rss&utm%5Fcampaign=understanding-fdas-risk-based-inspection-model-under-qmsr). “According to the updated Compliance Program document, these risks will be ‘used to evaluate whether a manufacturer is meeting requirements.’ FDA does not elaborate on how this will be done but does emphasize that investigators will need to use critical thinking skills to evaluate compliance and patient/product risk. In addition, FDA investigators will review external sources of information before arriving onsite – such as MDRs, trade complaints, and reports of correction and removals for similar products – to better understand the device’s overall risk profile.”

Previous inspections historically focused on four subsystems: Management Controls; CAPA (including MDR and removals); Design Controls; and Production and Process Controls. The new QMSR-aligned model expands that structure to six Quality Management System areas:

- Management Oversight
- Measurement, Analysis and Improvement
- Design and Development
- Change Control
- Outsourcing and Purchasing
- Production and Service Provisions

In addition, every inspection will review four “Other Applicable FDA Requirements”: MDR, Reports of Corrections and Removals, Medical Device Tracking (where applicable), and Unique Device Identification, the post says. Registration, listing, marketing authorization status and prior compliance history also remain in scope.

The post notes that FDA will deploy one of two inspection models depending on the inspection type:

- **Model 1**: Used for non-baseline surveillance, compliance follow-up, for-cause inspections, Specific Product Risk Assignment (SPRA) inspections, and PMA post-market inspections. Investigators must review at least one element in each of the six QMS areas, selected based on product risk.
- **Model 2**: Used for baseline surveillance and PMA preapproval inspections. This model requires a comprehensive review of all applicable elements within each QMS area, including design controls, CAPA functions, complaint handling, internal audits, sterilization validation (for sterile products), and outsourcing controls.

FDA also notes that because a QMS is a “set of linked processes,” findings in one area may lead investigators into other areas of the system.

Importantly, the post says FDA investigators may review records created before the 2/2 QMSR effective date. Although the former Quality System Regulation (QSR) and QMSR are largely aligned, the agency may use existing documentation to evaluate compliance under the new rule. This could have implications for companies with prior Voluntary Action Indicated or Official Action Indicated classifications, it says. Corrective actions taken under the old QSR framework will now be evaluated against QMSR requirements during subsequent inspections — even if those actions predated the new regulation.

The regulatory advisers recommend manufacturers conduct gap assessments to determine whether legacy documentation adequately demonstrates QMSR compliance.

The QMSR also explicitly authorizes FDA to review management review records, internal audit documentation, and supplier audit reports — materials that were not routinely inspected under previous inspections, the experts say. While these documents are commonly reviewed by ISO 13485 auditors, their formal inclusion in FDA inspection scope represents a notable shift. It remains unclear whether the expanded authority will influence how companies document internal audit findings or management discussions.

The regulatory experts recommend that companies familiarize staff with the new inspection structure and conduct mock audits aligned with the six-area framework. Reviewing prior inspection findings and reassessing CAPA documentation under QMSR standards may also reduce risk during initial inspections under the new model.