The record that used to stay in the boardroom
For decades, FDA investigators did not ask to see a device maker’s management review records. That changed on February 2, 2026, when the Quality Management System Regulation (QMSR) took effect. FDA’s new device inspection program, CP 7382.850, lists management reviews and internal quality audits as inspection elements, and FDA has dropped its policy of not requesting them (Ropes & Gray; King & Spalding).
For a quality director, management review is now evidence, not just governance.
Management Oversight is a QMS Area
CP 7382.850 organizes inspections into six QMS Areas, and Management Oversight is one of them. In most inspections (Model 1), investigators examine at least one element in every QMS Area, chosen based on risk. In baseline and PMA pre-approval inspections (Model 2), at least 22 or 23 prescribed elements are covered. Either way, leadership’s control of the quality system is on the table.
The program also makes risk management a stated inspection goal. Ropes & Gray list failures to establish risk management processes, to use current risk information in decision-making and to evaluate changes for risk as “Situation 1” findings that can contribute to an Official Action Indicated classification. Those are, at heart, management failures.
What a defensible management review shows
ISO 13485 sets the inputs and outputs of management review; QMSR now makes them visible to FDA. A record that will stand up to an investigator shows:
| Element | What good looks like |
|---|---|
| Inputs | Complaints, feedback, CAPA, audit results (internal, supplier, external), process and product monitoring, changes, regulatory changes, risk information, previous actions |
| Analysis | Trends and what they mean, not just tables |
| Decisions | Explicit decisions on improvement, resources and changes needed to stay compliant |
| Actions | Owners, due dates and links to CAPA or projects |
| Follow-up | Status of previous actions at the next review |
| Attendance | Top management present, with authority to commit resources |
The weak record lists data and closes with “no actions”. An investigator reading that next to a backlog of overdue CAPAs will draw their own conclusion.
Five changes quality directors are making
1. Treat the record as an external document
Write minutes in factual, evidence-based language. Avoid both alarm and spin; either will be quoted back.
2. Put risk on the agenda every time
Show how post-market data (complaints, MDRs, recalls, servicing) updated the risk picture and what decisions followed. This is the clearest way to show “use of current risk information in decision-making”.
3. Bring supplier and outsourcing data in
Outsourcing and Purchasing is also a QMS Area, and FDA can now read supplier audit reports. Purchasing controls (820.50) were the third most-cited device observation in FY2025 with 115 citations (GMP Insiders).
4. Track CAPA effectiveness at leadership level
CAPA procedures (820.100(a)) were the most-cited device observation in FY2025, with 279 citations. Management review should show not just how many CAPAs are open, but whether closed ones worked.
5. Prepare to explain it
The director may be the person an investigator asks to walk through management review decisions. Rehearse that conversation.
Who you work with
- CEO, COO and site leaders: top management who must attend and decide.
- Quality managers and site quality heads: inputs and actions.
- Regulatory affairs: regulatory changes, MDR and recall data.
- R&D and operations leaders: resource decisions.
- Legal: language in records that may be read externally.
Common weaknesses
- Management review held but top management absent or represented by delegates without authority.
- Inputs presented without analysis or decisions.
- Actions without owners or due dates.
- Risk management missing from the agenda.
- Previous actions not followed up.
Checklist
- All ISO 13485 inputs covered, including risk and supplier data
- Decisions and actions recorded with owners and dates
- CAPA effectiveness reviewed
- Previous actions closed or escalated
- Minutes reviewed for factual, inspection-ready language
- Director rehearsed for an investigator walkthrough
How AskDona helps
Management review pulls together evidence from across the quality system. AskDona reads your management review records alongside CAPA, complaint and audit records, checks that required inputs are present and that actions are followed up, and cites the source page for every finding. Run a sample management-review evidence check on your last two reviews. AskDona shows the evidence; your quality leadership decides.
Editor’s note: Based on law-firm analyses of QMSR and CP 7382.850 from February 2026; not legal advice. The input list summarizes typical ISO 13485 management review inputs; the standard’s text is copyrighted. The LinkedIn count was supplied by the client.
FAQ
Can FDA see management review records now? Yes. Under QMSR and CP 7382.850, management reviews are inspection elements.
What is Management Oversight? One of the six QMS Areas in FDA’s new device inspection program.
What makes a management review record weak? Data without analysis, decisions or actions, and no follow-up of previous actions.
Does MDSAP change this? MDSAP participants still have routine surveillance inspections waived, but for-cause inspections remain possible.
References
All pages opened and checked by October 23, 2026.
| Source | Type | Used for |
|---|---|---|
| Ropes & Gray: A QMSR state of mind (Feb 17, 2026) | Law firm analysis | Management review inspectable, Situation 1 findings |
| King & Spalding: The QMSR goes live (Feb 3, 2026) | Law firm analysis | Inspection models, MDSAP |
| GMP Insiders: FY2025 FDA inspection observations | Industry analysis | CAPA and purchasing citation counts |