FDA device inspections changed on February 2, 2026
When the Quality Management System Regulation (QMSR) took effect on February 2, 2026, FDA also replaced the way it inspects device manufacturers. The Quality System Inspection Technique (QSIT), used since the late 1990s, gave way to a revised compliance program, CP 7382.850, built around ISO 13485 and risk (FDA CP 7382.850). If your inspection readiness program still follows QSIT’s four subsystems, it is out of date.
The context matters too. FDA cut about 3,500 staff in 2025 (MedTech Dive), and Hogan Lovells notes an “overall decrease in the number of inspections over the past decade” (Hogan Lovells). Yet quality system warning letters rose: 19 in 2025 through September 4, compared with 12 in the same period of 2024. Inspections may be less frequent, but they are not less consequential.
For FDA inspection types across product areas and a readiness plan, see FDA Inspections in 2026: Types, What to Expect and an Inspection Readiness Plan.
Types of FDA medical device inspections
CP 7382.850 defines several inspection types (FDA):
| Type | Purpose | Notes |
|---|---|---|
| Surveillance (baseline) | First comprehensive inspection, or one after a long gap | Covers all QMS areas in depth |
| Surveillance (non-baseline) | Routine follow-up inspection | Scope driven by risk and history |
| Compliance follow-up | Checks correction of prior violations | Often after a warning letter or OAI |
| For-cause | Responds to a specific signal, such as complaints, recalls or a tip | Can happen at any time, including at MDSAP participants |
| Special Premarket Regulatory Assessment (SPRA) | Supports premarket review decisions | Linked to specific submissions |
| PMA preapproval / postmarket | Confirms manufacturing for PMA devices | Required before PMA approval |
One important exception: “Surveillance inspections are not conducted at manufacturers actively enrolled in MDSAP” (FDA CP 7382.850). For-cause and other inspection types still apply.
How FDA inspects: six QMS areas
Under CP 7382.850, investigators organize their work into six QMS areas:
- Change control
- Design and development
- Management oversight
- Measurement, analysis and improvement
- Outsourcing and purchasing
- Production and service provision
Within those areas, the program lists specific inspection elements. King & Spalding explains that the new approach requires coverage of at least 22 elements, or 23 for sterile devices (King & Spalding). Risk management is evaluated across all areas rather than as a separate checkpoint.
Records FDA can now see
Under QMSR, “The exceptions that existed in the QS regulation at § 820.180(c) are not maintained” (FDA QMSR FAQ). Investigators can review management review records, internal quality audit reports and supplier audit reports, which were previously shielded.
What early QMSR inspections are finding
In May 2026, an FDA official told RAPS that “Risk management is the top observation” in QMSR inspections so far, followed by outsourcing problems, complaint handling, UDI systems and corrective actions (RAPS).
What happens during an FDA inspection
- Notice. Domestic inspections are typically pre-announced a few days ahead, though for-cause inspections may not be. Foreign inspections are increasingly unannounced (see below).
- Opening. Investigators present credentials and Form FDA 482, the notice of inspection.
- Walkthrough and records review. Investigators follow the six areas, sampling records such as complaints, CAPAs, design changes and validations, and tracing them across processes.
- Daily debriefs. Many investigators share concerns as they go; use these to clarify and provide evidence promptly.
- Close-out. Observations, if any, are listed on Form FDA 483 and discussed at the closing meeting.
- Report. The investigator writes an Establishment Inspection Report (EIR), and FDA classifies the inspection outcome.
Inspection outcomes and what follows
FDA classifies each inspection as one of three outcomes (FDA):
| Classification | Meaning | Typical next step |
|---|---|---|
| NAI: No Action Indicated | No objectionable conditions found, or none justifying further action | None |
| VAI: Voluntary Action Indicated | Objectionable conditions found, but FDA will not take or recommend regulatory action | Firm corrects voluntarily |
| OAI: Official Action Indicated | Regulatory or administrative action will be recommended | Warning letter, import alert, injunction or other action |
If you receive a Form FDA 483, respond in writing within 15 business days. FDA generally considers responses received in that window when deciding whether to issue a warning letter, so a complete, evidence-backed response can change the outcome.
Remote regulatory assessments
FDA finalized its guidance on remote regulatory assessments (RRAs) on June 26, 2025. As Sidley summarizes, RRAs are not inspections under section 704 of the FD&C Act and do not result in a Form 483, but refusing a mandatory RRA (a records request under section 704(a)(4)) is a violation of the FD&C Act (Sidley). In practice, that means your records must be retrievable and understandable without a person standing next to them to explain.
Foreign sites: more unannounced inspections
In May 2025, FDA announced expanded use of unannounced inspections at foreign manufacturing facilities. The agency said it conducts about 12,000 domestic and 3,000 foreign inspections a year across all product areas, and that foreign facilities were found to have serious deficiencies “more than twice as often” as domestic ones (FDA). Emergo by UL confirmed that the expansion applies to device manufacturers (Emergo by UL). Foreign sites, and US companies relying on foreign contract manufacturers, should be ready on any given day.
Product inspection: the other meaning of “medical device inspection”
Inside the factory, “inspection” also means checking product: receiving inspection of incoming materials, in-process inspection and final acceptance before release. ISO 13485 requires monitoring and measurement of product, with records of acceptance and the person authorizing release, and QMSR keeps FDA-specific requirements for labeling and packaging inspection in §820.45 (eCFR Part 820).
FDA’s final rule cautions that “manufacturers should not rely solely on inspection and testing” (Federal Register). Inspection must be backed by validated processes. Staffing is part of the picture too: the Bureau of Labor Statistics reports a median wage of $48,570 for quality control inspectors across industries, with projected growth of 3% (BLS), which is one reason automated and vision-based inspection is spreading.
FDA inspection readiness checklist
Before the inspection
- Procedures and records mapped to ISO 13485 clauses and Part 820, not QSIT subsystems
- Evidence organized by the six QMS areas, with an index for fast retrieval
- Management review, internal audit and supplier audit reports reviewed for accuracy and follow-up
- Risk management traceable from the risk file to design, production, complaints and CAPA
- Complaint files show MDR decisions; CAPAs show verified root causes and effectiveness
- Records retrievable remotely for RRAs
- Foreign sites and contract manufacturers prepared for unannounced inspections
During the inspection
- Front-room host, scribe and subject matter experts assigned
- Back room retrieves and reviews documents before they are presented
- Daily debrief to address concerns before the close-out
After the inspection
- 483 response with root cause, correction, corrective action and evidence within 15 business days
- Commitments tracked to closure and verified
- EIR reviewed when received; lessons fed into the audit program
Find what the investigator would find, first
The fastest inspections are the ones where every requested record is complete and consistent. AI document assessment can review procedures and records against QMSR and ISO 13485, flag gaps and cite the passage behind every finding, so your team can fix issues before an investigator sees them.
Run a sample regulatory document assessment on one QMS area. AskDona shows the evidence; your team decides.
FAQ
How does FDA inspect medical device manufacturers in 2026? Using compliance program CP 7382.850, organized into six QMS areas, replacing QSIT since February 2, 2026 (FDA).
Does FDA announce device inspections? Domestic inspections are usually pre-announced; FDA has expanded unannounced inspections at foreign sites (FDA).
What is the difference between a 483 and a warning letter? A 483 lists an investigator’s observations at the end of an inspection. A warning letter is an agency enforcement action that may follow if violations are significant or responses are inadequate.
Can a remote regulatory assessment result in a 483? No, RRAs do not result in a 483, but findings can inform further action (Sidley).
References
All pages opened and checked by October 13, 2026.
| Source | Type | Date | Used for |
|---|---|---|---|
| FDA: CP 7382.850 | Regulator | Feb 2, 2026 | Inspection types, six areas, MDSAP |
| King & Spalding: QMSR goes live | Law firm | 2026 | Inspection elements |
| FDA: QMSR FAQ | Regulator | 2026 | Records access |
| RAPS: Top QMSR observations | Professional body | May 14, 2026 | Early findings |
| FDA: Inspection classifications | Regulator | Current | NAI/VAI/OAI |
| Sidley: RRA final guidance | Law firm | Jul 2025 | RRAs |
| FDA: Unannounced foreign inspections | Regulator | May 6, 2025 | Inspection volumes |
| Emergo by UL: Unannounced inspections | Consultancy | May 8, 2025 | Device scope |
| Hogan Lovells: Device inspections in 2025 | Law firm | 2025 | Trends, warning letters |
| MedTech Dive: FDA layoffs | Trade press | May 6, 2025 | Staff cuts |
| eCFR: 21 CFR Part 820 | Regulation | Current | §820.45 |
| Federal Register: QMSR final rule | Regulation | Feb 2, 2024 | Inspection vs validation |
| BLS: Quality control inspectors | Government | Current | Wages, outlook |