Another QMSR Town Hall – What Changes and What Stays the Same in FDA’s Inspection Process

With the Quality Management System Regulation (QMSR) compliance date of February 2, 2026, FDA has been convening a series of town hall discussions to help industry with compliance.  In our previous post we discussed FDA’s final town hall prior to the compliance date and the Agency’s emphasis on risk, design, and culture of quality.  On April 1, FDA held another town hall that reviewed the updated Inspection of Medical Device Manufacturers Compliance Program Manual (CP-7382.850) (the CP), which we blogged about previously.

In the opening remarks, FDA summarized the two inspection models and noted that unlike prior inspections under the Quality System Inspection Technique (QSIT) that each inspection will include evaluation of each area of a company’s Quality Management System (QMS).  After the summary, FDA turned to a panel of experts who responded to frequently asked questions related to FDA inspection under QMSR and the new CP.

There were several points made by the panel that are worth highlighting.

Risk-based approach

FDA noted that while they previously requested risk management (RM) documentation during QSIT inspections, under QMSR inspections they will emphasize RM documents and risk controls throughout the QMS. During inspections, FDA will review RM files and reports for products, risk analysis (hazard/harm), documentation showing how risk controls are implemented, and documentation to show risk controls are effective.

When asked about methodology to assess risk in different areas of the QMS, FDA noted that different processes carry different levels of risk and that manufacturers can use different RM approaches as long as the approach used is appropriate for risks involved and risk-based decisions are documented in the QMS.  FDA stated that the risk-based approach for administrative processes, such as document control or training,  is different from the formal risk process used to evaluate product risk under clause 7.1 of ISO 13485.  FDA noted that manufacturers will not need separate risk assessments for administrative processes.  Instead, when making decisions, manufacturers should reference risk documents related to the product.  As an example, FDA noted that risk documentation related to the manufacturing process may be used to determine training frequency.  FDA did not, however, explain what happens when an entity is not the owner of the product risk documentation.  For example, when the establishment is the contract manufacturer and does not own the design or it is merely the initial importer.  As with other town halls, FDA did not take questions from the audience during this one either.

Inspection Technique

FDA noted that the inspection process will be largely the same under the CP as it was under QSIT, though there are some notable differences.  What isn’t changing is that investigators will still provide a Form 482, tour the facility, ask to see how products and processes work, ask about roles and responsibilities, review quality data and documents, observe and watch processes in action, and issue a Form 483 for any inspectional observations, which can be annotated or responded to in writing after the inspection.  Specific documents and evidence reviewed will continue to depend on the risk of the device and priorities for the inspection, and the threshold for compliance action has not changed.

One difference in inspections under the CP is that a statistical sample, as used in QSIT inspections, is not required.  Investigators will conduct record review as they deem appropriate, with the number and type of records being selected based on product risk, and the investigators’ experience and professional knowledge.

As noted above, unlike QSIT inspections, each Model 1 or Model 2 inspection under the CP will evaluate all applicable QMS areas and Other Applicable FDA Requirements, with Model 1 inspections evaluating at least one element in each area and Model 2 inspections evaluating all elements.  FDA noted that in Model 1 inspections, the number of elements reviewed is the minimum and is flexible, allowing inspectors to expand as needed in accordance with a risk-based approach.  FDA noted that investigators will typically cover more than one element to ensure risks are controlled.

QMSR inspections will now include review of management review, internal audits, and supplier audits, which were out of scope in previous inspections under the Quality System Regulation.  When asked how far back inspectors will look at records for management review and audits, and what guidance inspectors are given for review of these new record types, FDA noted that for baseline inspections and pre-approval inspections, these records will be specifically requested.  In other inspections, FDA expects to use their findings to determine when to review these records.  For example, if the inspection identifies issues in design, the inspector may look at how internal audits have evaluated design.

FDA additionally commented that inspections will not follow the Medical Device Single Audit Program (MDSAP) approach and that there are no additional guidance documents planned to support the CP.

Culture of Quality

In prior town hall discussions, FDA emphasized the need for a culture of quality.  When asked how to demonstrate a culture of quality, FDA stated there are no special steps to document quality culture – it is reflected in decisions made and actions taken throughout the QMS.  FDA investigators will look at how manufacturers operate and make risk-based decisions.

FDA also noted that the manufacturers should ensure the internal audit program is evaluating how risk management is integrated throughout product development, how a risk-based approach is used throughout the QMS, and how risk controls are implemented in each impacted process.

FDA’s most recent QMSR town hall discussion provided valuable insight into how inspections will be conducted and where investigators will focus their attention. While many elements of QMSR inspections will feel familiar, the shift toward evaluating the entire QMS, the increased emphasis on risk management integration, and the broader discretion afforded to investigators represent meaningful changes that manufacturers should not underestimate.