FDA replaces QSIT with new Compliance Program Manual

To coincide with mandatory use of the Agency’s Quality Management System Regulation (QMSR, 21 CFR 820) requirements, FDA has also replaced its ‘Quality System Inspection Technique’ (QSIT) guidance for Inspectors with a ‘Compliance Program Manual: Inspection of Medical Device Manufacturers’, with effect from 2 February 2026, explaining that the program has been updated to align with the QMSR requirements. The document will also replace the ‘Medical Device PMA Preapproval’ and ‘PMA Postmarket Inspections’ guidelines.

The 78 page manual explains that the new inspection approach “encompasses a total product life cycle (TPLC) assessment of medical devices1 while making compliance and enforcement decisions informed by benefit-risk, including reliable information relating to patient perspectives on acceptable benefit-risk when
available,”  as required by The Safeguarding Therapeutics Act. It also includes a new diagrammatic overvue of the updated inspection methodology.

Per the new diagram, patients and users are the central focus of FDA medical device inspections and are depicted at the center. The risk management circle surrounding patients and users represents FDA’s emphasis on using a manufacturer’s risk management documentation to help focus the inspection on risk.

Each QMS Area is comprised of one or more “elements”. Each element includes one or more regulatory requirements.

The goal of FDA inspections of medical device manufacturers is restated in the document as being to evaluate if the manufacturer’s:
– QMS meets FDA requirements and provides reasonable assurance that devices will be safe and effective
– Risk management and risk-based decision making are effectively used in the QMS

In addition, for FDA staff, the objectives of this program are:
– to conduct risk-based inspections of medical device manufacturers and identify manufacturers who are not in compliance with the regulations, and
– to bring these manufacturers into compliance through voluntary, advisory, administrative, and/or other regulatory means, as appropriate, or determine the
approvability of a PMA based on the manufacturer’s ability to produce safe and effective medical devices

The guidance recommends that inspections should be scheduled against the following priorities, utilizing a risk-based methodology:

(1) PMA preapproval inspections under Medical Device User Fee Amendments (MDUFA).
(2) Compliance follow-up and for-cause inspections
(3) Manufacturers of Class III devices that have never been inspected(4) Manufacturers of high-risk devices which can be identified by:
(a) Product Codes for implantable, life-sustaining devices or life-supporting devices
(b) Devices with a higher frequency of recalls and MDRs
(c) Newly marketed devices such as recent 510(k) clearances or De Novo classifications
(5) PMA postmarket inspections

The Agency’s Compliance Program webpage has been updated to include the new manual, and  a complete copy of the manual is available from here.