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FDA's New QMSR Device Inspection Requirements
- Introduction to the QMSR
- Key Changes
- "Incorporation by reference" ISO 13485, and ISO 9000, Clause 3
- The new 21 CFR 820 "plus"
- Areas of concern for compliance; per FDA Inspection Manual 7382.850
- Major Areas of Emphasis over ISO 13485
- Incorporation of risk management throughout the quality system based on ISO 14971
- US FDA Inspection Expectations
Overview of the webinar
The US FDA, a has published their QMSR 21 CFR 820, to replace the previous QSR 21 CFR 820, Medical Devices, implemented February 02, 2016. They also released their new Device Inspection Manual 7382.850, on the same date, with the focus on Patient / User Risk Management. The Quality Management System Regulation (QMSR) revises 21 CFR 820 to include ISO 13485:2016 (and ISO 9000 Clause 3) by reference. FDA inspections will transition to a process aligned with ISO 13485, described in the FDA Inspection Manual. This is a shift from QSIT’s subsystem model to a process-focused inspection approach, with a heavier emphasis on risk management.
This webinar will discuss what the new QMSR and its inspection will require. A key element is the incorporation of ISO 13485 into the new 820 by reference. Major emphasis will be upon risk management in accordance with ISO 14971 (-:2019), which currently has only casual reference in 820.30. The FDA views patient/user risk management as an “essential systematic practice” to ensure that devices are safe and effective. If the proposed rule is finalized, it will enhance some parts of ISO 13485. Device manufacturers will need to enhance risk management procedures for specific devices and in all other areas of their businesses to align with the QMSR. Design Control (ISO 13485 7.3 Design and Development) basically is unchanged. The QMSR will re-emphasize senior management's importance establishing and following a policy of quality, and a company culture of quality. The concept and definition of the make-up and role of "the customer", a term familiar to ISO but not the old QSR. There are other changes which will be discussed during this webinar. Combination products, 21 CFR 4, will be modified to include reference to ISO 13485 as well. QSIT will be eliminated, replaced with the FDA's Inspection Manual 7382.850. ISO 13485 inspections will not be harmonized. There was a two year transition period, which ended on February 02, 2026.
Who should attend?
- Senior management in Devices, Combination Products
- QA / RA
- Medical Device product development teams
- R&D
- Engineering
- Production
- Operations
- Marketing
- Consultants
Others tasked with device QA, product development, manufacturing, process / product / data analysis, regulatory submission responsibilities
Why should you attend?
The FDA has been working to align its QSR with the worldwide quality systems standard ISO 13485. 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.” 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 QSIT inspection focus has been basically eliminated, replaced with their new Device Inspection Manual 7382.850, with a focus on Patient / User risk. This webinar will address the key areas of the new QMSR and how they are to be inspected by the FDA per their new Manual.
Faculty - Mr.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, 27 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. 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, CAPA systems and analysis. 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 ptublished numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.