FDA Retires QSIT as QMSR Takes Effect and Device Inspections Turn Risk-Based

The FDA's new device quality rule took effect on Monday, and with it the agency changed how its investigators inspect medical device manufacturers. On February 2, 2026, the FDA "stopped using the Quality System Inspection Technique (QSIT) for device inspections," the agency said on its Quality Management System Regulation page, and began using the process set out in an updated compliance program, numbered 7382.850.

The Quality Management System Regulation, or QMSR, amends the device current good manufacturing practice requirements in 21 CFR Part 820 by incorporating by reference ISO 13485:2016, the international standard for medical device quality management systems. The FDA said the change harmonizes its framework with the one used by other regulatory authorities. Where a clause of ISO 13485 conflicts with the Federal Food, Drug, and Cosmetic Act or its regulations, the US law controls, the agency said.

One manual replaces two

The new program, Inspection of Medical Device Manufacturers (CP 7382.850), carries an issuance and implementation date of February 2, 2026. It supersedes the program of the same name issued on September 29, 2023, previously numbered 7382.845, and the separate program for PMA preapproval and postmarket inspections, 7383.001, issued in 2012, according to the document. The program provides instruction to FDA field and center staff for inspections and for administrative and enforcement activities under the QMSR and related device regulations, including medical device reporting, corrections and removals, registration and listing, and unique device identification.

Under the program, investigators organize the regulation's requirements into six "QMS Areas": change control; design and development; management oversight; measurement, analysis and improvement; outsourcing and purchasing; and production and service provision. Four "Other Applicable FDA Requirements" sit alongside them: medical device reporting, reports of corrections and removals, device tracking, and unique device identification.

The document says investigators should review a manufacturer's risk management documentation throughout an inspection to understand product risks and the controls on them, and then select which elements to examine. In routine surveillance inspections of firms previously inspected, investigators must evaluate at least one element in each QMS Area and each of the four other requirements. The areas need not be covered in a set order.

Who gets inspected first

The program tells the FDA's Office of Inspections and Investigations to schedule device inspections by risk. Its listed priorities are PMA preapproval inspections, with expedited PMAs first; compliance follow-up and for-cause inspections; manufacturers of Class III devices that have never been inspected; makers of high-risk devices, including implantable or life-sustaining products, devices with more recalls and adverse event reports, and newly cleared or De Novo-classified devices; and PMA postmarket inspections. Class I manufacturers "should not be routinely scheduled for inspection" unless there is a for-cause assignment or an apparent health hazard, the document says.

Sites actively enrolled in the Medical Device Single Audit Program are not given surveillance inspections, the program says, and investigators are told to consult a supervisor before inspecting an MDSAP participant on another type of assignment.

The FDA said it will no longer use the two superseded compliance programs after February 2. Its QMSR page lists the final rule, an AAMI guide to ISO 13485 and a mapping of FDA regulations to the standard among resources for manufacturers.