The New US FDA 21 CFR 820, Quality Management System Regulation (QMSR), Medical Device CGMPs

John E Lincoln Instructor:
John E Lincoln 
90 Minutes
Webinar ID: 501860

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Price Details
Recorded Webinar
$199 One Attendee
$399 Corporate Recorded

Recorded: Access recorded version, only for one participant unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)

Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)


This webinar will discuss what the new QMSR 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 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) will have limited application to Class I devices, but fully involve Class II and III (US classifications) as is currently done in the US but not the EU.

Traceability of implantables will be emphasized more than in ISO 13485. The QMSR will re-empbasize senior mangement'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 changed. The FDA's new inspection program would not be a substitute for an ISO 13485 certification procedure if one is required, nor would those who hold an ISO 13485 certificate be exempt from FDA inspection. There will be a two year transition period allowed, from the date of publication in the Federal Register of February 02, 2024..

Why you should Attend: 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 FDAwill give manufacturerstwo years from the publication of the final rule on February 2, 2024, to adapt to the new regulatory requirements.
Areas Covered in the Session:

  • Introduction to the QMSR
  • "Incorporation by reference" ISO 13485
  • The new 21 CFR 820
  • Key Changes
  • Major Areas of Emphasis over ISO 13485
  • Incorporation of risk management throughout the quality system based on ISO 14971
  • Phase-in period

Who Will Benefit:
  • 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

Speaker Profile
John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide.

John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.

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