FDA’s New Medical Device QMSR: ISO 14971 and Patient Risk Management

Presenter: John E. Lincoln, B.S., CQE, CQA, RAC
Date: Wednesday, February 17, 2027
Time: 1 pm ET | 12 pm CT | 11 am MT | 10 am PT
Duration: 90 minutes

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Course Description

The US FDA has published its QMSR to replace the previous QSR, 21 CFR 820, Medical Devices. The implementation deadline was February 02, 2026. The Quality Management System Regulation (QMSR) revises 21 CFR 820 to include ISO 13485:2016 (and ISO 9000m Clause 3) by reference.

A key change is the major emphasis on patient/use risk management per ISO 14971:2019. For FDA inspections, QSIT has been replaced by their new Inspection Manual 7382.850, effective on the same date. This is a shift from the old QSIT’s subsystem model to a process-focused inspection approach, with a heavier emphasis on risk management, and a resultant hybrid compliance burden between a company's legacy QSR requirements and new harmonized ISO 13485-based expectations of the QMSR.

The FDA has been working for years 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 products 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’s emphasis on people risk management is not new. But the CGMP emphasis on risk is made substantially more obvious. The FDA has given manufacturers two years (to February 02, 2026) to adapt to the new regulatory requirements. As stated, QSIT has also been basically eliminated, though its basic principles remain.

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Learning Outcomes

• Key Points of the New Device QMSR
• New QMSR Issues in the Final Rule and Preamble
• The Major Emphasis on Patient /User Risk Management per ISO 14971:2019
• The QMSR Inspection Requirements of the FDA’s New Device Inspection Manual
• The Key Change in FDA’s Inspection Policy on Company Audit Reports and Management Reviews
• What is “Incorporation by Reference”
• Why the New Subparts A and B in the new 21 CFR 820
• Expected Changes to a company’s SOPs, WIs, and QM
• Unique Field Experiences with the FDA on Device Risk Management.

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Areas Covered in the Session

• Device QMSR Final Rule, 21 CFR 820
• Preamble to Final Rule
• FDA’s New Device Inspection Manual 7382.850
• FDA’s Inspection Focus Diagram
• ISO 13485 Clauses and Areas for Inspection
• 21 CFR 820 Subparts A & B and the FDA’s FD and C Act
• IS0 14971:2019 Basics
• A Device Risk Management SOP, vetted by the FDA
• A Device Risk Management File, vetted by the FDA
• Sample File Documents, Hazard List, FDA, FMEA, vetted by the FDA
• Audit Plans
• Audit Checklists
• Audit Reports, Draft and Final
• Follow-up
• A Typical Audit Sequence – FDA and Internal / Vendor
• Live Q&A Sessions

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Recommended Participants

• Senior management in Devices, Combination Products
• QA/RA
• Medical Device product development teams
• R&D
• Engineering
• Sales and Marketing
• Operations
• Manufacturing

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About the Presenter  

John E. Lincoln, B.S., CQE, CQA, RAC is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 44 years of 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, up to the level of Director and VP (R&D). He was selected as one of two representatives for the state of Utah’s Industrial QA/RA representatives to an FDA District Meeting by the FDA Resident Post in Utah. In addition, John has prior experience in the military, government, electronics, and aerospace. He has published numerous articles in peer-reviewed journals, chapters in books including RAPS (6 chapters in 2 books on V&V), conducted workshops and webinars worldwide on these same issues. John is a graduate of UCLA.

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