FDA Inspections After QMSR: What Replaces QSIT 2.0 - The New Inspection Reality

The US FDA, a has finally published their QMSR to replace the previous QSR. Implementation deadline is February 02, 2026. The Quality Management System Regulation (QMSR) revises 21 CFR 820 to include ISO 13485:2016 (and ISO 9000 Clause 3) by reference. For FDA inspections, no QSIT 2.0 on the way. Instead, FDA inspections will transition to a process aligned with ISO 13485, described in the Medical Device Compliance Program. This is a shift from QSIT’s subsystem model to a process-focused inspection approach, a heavier emphasis on risk management, and a resultant hybrid compliance burden between a company's legacy QSR requirements and new ISO-based expectations of the QMSR.

The FDA has been working to align its QSR with the worldwide quality systems standard ISO 13485. Part of the reason for harmonizing its regulations with ISO 13485 is to reduce the regulatory burden for device makers who sell product in both the US and in EU / Asia, by eliminating redundancies involved in complying with both the ISO and QSR standards. After years of reviews, the Agency has “determined that the requirements in ISO 13485 are, when taken in totality, substantially similar to the requirements of the current Part 820, providing a similar level of assurance in a firm’s quality management system and ability to consistently manufacture devices that are safe and effective and otherwise in compliance with the FD&C Act.” They base this decision on their participation in the Medical Device Single Audit Program (MDSAP), as well as a previous audit report pilot program in which the Agency accepted manufacturers' audit reports based on ISO 13485 (-:2003). FDA agrees that ISO 13485 represents a more modern QMS approach and “has greater integration of risk management activities and stronger ties to ISO 14971, the risk management standard for medical devices". The FDA had given manufacturers two years (to February 02, 2026) to adapt to the new regulatory requirements. QSIT has also been basically eliminated.

Areas Covered in the Session : 

• Introduction to the QMSR
• "Incorporation by reference" ISO 13485
• The new 21 CFR 820 "plus"
• Key Changes
• Major Areas of Emphasis over ISO 13485
• Incorporation of risk management throughout the quality system based on ISO 14971
• No "QSIR 2.0". What?

Who Should Attend:

• Senior management in Devices, Combination Products
• Quality Assurance Departments
• Regulatory Affairs Departments
• Medical Device product development teams
• Research and Development Departments
• Engineering Departments
• Production Departments
• Operations Departments
• Marketing Departments
• Consultants; others tasked with device QA, product development, manufacturing, process / product / data analysis, regulatory submission responsibilities

Course Director: JOHN E. LINCOLN

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 40 years experience in U.S. FDA-regulated industries, 30 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100,worldwide. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles and book chapters (including 5 chapters in 2 RAPS V&V textbooks) in peer reviewed publications, conducted workshops and webinars worldwide. John is a graduate of UCLA.