Learn about the future of FDA's Quality Management System regulation. This presentation originally aired during the 2022 Future of QMS Requirements Virtual Summit.

1. TUV SUD Speaker:
Dr. Deepa Pandia
Presentation for
Greenlight Guru Virtual Summit
QMSR Harmonization:
Future of FDA's Quality
Management System Regulation
2 Nov 2022
TÜV SÜD AMERICA | QMSR Harmonization, Presentation for Greenlight Guru Virtual Summit

2. I. FDAs Intention and Proposal
II. Background and ISO 13485:2016
III. Goal of the proposed QMSR
IV. Key Modifications
V. Quality Systems Inspection Protocol and
MDSAP
VI. Impact on Industry
VII. Timelines
VIII. Summary and Takeaways
IX. Questions & Resource Pages
I. FDAs Intention and Proposal
II. QMSR, FDA and ISO 13485:2016
III. Goal of the proposed QMSR
IV. Key Modifications
V. Implementation and Quality Systems
Inspection (QSIT)
VI. Timelines and Takeaways
VII. Questions & Feedback
VIII. Resource Pages
Agenda
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3. 1. Revise 21 CFR 820 with an Incorporation by
Reference (IBR) with International standard ISO
13485:2016
2. Additional requirements to align with existing
requirements in ISO 13485
3. Make conforming edits to CFR to clarify
requirements for combination products
4. Reduce burden of compliance and recordkeeping
on device manufacturers
Proposed Regulation: Federal Register: Medical
Devices; Quality System Regulation Amendments
I. FDAs Intention and Proposal
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4. ISO 13485:2016 Medical Devices – Quality Management
Systems – Requirements for Regulatory Purposes
§Standard establishes requirements for a QMS that can be used
by an organization involved in one or more stages of life-cycle of
a medical device.
§QMS Principles in this standard have risk management ties to
ISO 14971
§Requirements presented in this ISO 13485 are similar to 21
CRF part 820.
II. ISO 13485:2016, 21 CFR 820, FDA and International Standards
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5. § 1978 - 21 CFR part 820 first authorized
§ 1996 - Significant revision made to 21 CFR part 820
§ 1996 - ISO issues 1st Edition of ISO 13485
§ 1996 - FDA Participates in International Standards and global harmonization efforts
§ 2003 - ISO issues 2nd Edition of ISO 13485
§ 2005 - Global Harmonization Task Force involved with guidance documents on implementation of Risk
Management Principles and Activities Within a Quality Management System
§ 2006 - PMAP (no longer used)
§ 2012 - Voluntary Audit Report Submission Pilot Program
§ 2016 - ISO issues 3rd Edition of ISO 13485
§ 2017 - MDSAP audits conducted on bases of ISO 13485 and development of country specific
requirements for USA
§ 2018 - FDA began incorporation of ISO 13485
§ 2022 - Feb FDA publishes proposed QMSR
§ 2022 - Mar FDA holds Public Advisory Committee Meeting
II. 21 CFR 820, FDA and International Standards
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6. 1. Reduce burden on manufacturers
2. Maintain similar level of assurance in QMS
– Manufacuturers to use good judgement when developing their QMS. Work may be
delegated however responsibility for meeting requirements may not be delegated
3. Ability to consistently manufacture safe and effective devices
4. Device Flexibility:
– Maintain flexibility of the QS Regulation to apply to different types of devices
5. Organizational Flexibility:
– Regulation to not prescribe how a QMS should be structured rather the regulation provides
the framework that should be followed.
III. Goal of the proposed QMSR
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7. 2-Nov-22
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IV. Key Modifications
§ Amend the title of the regulation –
Quality Management System Regulation
(QMSR)
§ Add FDA-specific requirements and
provisions that clarify certain concepts
used in ISO 13485.
§ Retain the scope of the current regulation
§ Impact to definitions in the current part
820.3

8. §Four Differences in Proposed Rule 820.35 and 820.45 below
IV. Key Modifications
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Current Subpart
of part 820
Equivalent ISO
13485:2016 Clause
Area of differences
Subpart D Clause 4 Quality Management systems,
Document controls
Subpart K Clause 7 Product realization,
Labeling and packaging control
Subpart M Clause 4 Quality management systems,
Records
Subpart N Clause 7 Production realization,
Servicing

9. § Applicable Regulatory Requirements
– Regulated manufacturers are responsible for identifying and meeting all applicable requirements, even if such
requirements are not specifically called out in the proposed § 820.10
§ Risk Management
– Risk management requirements are integrated throughout aspects of quality management system in ISO 13485.
– 21 CFR 820 risk-specific requirements are presented in
i. 820.100 CAPA process risk assessment
ii. 820.30(g) Design validations, risk assessment reference
§ Design Controls Requirements
– This is Not a change just clarification in the QMSR. Design control requirements still applicable to all Class II and III
devices but only devices listed in the provision for Class I will be subject to design controls
§ Traceability Requirements
– Proposing to add a requirement for devices that support or sustain life comply with the traceability requirements set forth
in in Clause 7.5.9.2 of ISO 13485.
– § 820.65 for traceability includes this however, in ISO 13485 is only for implantable devices
IV. Key Modifications
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10. § Clarifications
– Organization as defined in ISO 13485 to include definition of the term ‘manufacturer’ per 820.3
– ISO 13485 uses Safety and Performance construe this as Safety and Effectiveness for QMSR
– Validation of processes per ISO 13485 to refer to Process Validations per 820.3(z)(1)
§ Conforming edits to part 4 (21 CFR part 4) to clarify the device QMS requirements for combination products. No impact to
CGMP requirements.
NOTE:
Any future revisions to ISO 13485 would need to be evaluated to determine the impact of the changes and whether this rule,
if finalized, should be amended. If deemed necessary and appropriate, FDA will update the final regulation in accordance
with the Administrative Procedure Act (5 U.S.C. 553) and obtain approval of any changes to the incorporation by reference in
accordance with 1 CFR part 51.
IV. Key Modifications
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11. 1. Updating/changing information technology (IT) infrastructure to
support future inspection to align with ISO 13485
2. Training FDA/CDRH staff responsible for assessing compliance
with medical device quality management system requirements
3. Developing an inspection technique or changing QSIT
4. Revising relevant regulations and other documents impacted by
this rulemaking, and
5. Communicating and educating stakeholders
6. Revise and update several internal documents
Other impacts to FDA will be the Premarket and post market
programs additional guidance documents awaited for clarity.
V. Implementation Activitites and Quality
Systems Inspection
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12. I. Changes discussed will likely result in transition
periods of a few years
II. AAMI Development of a TIR – Technical Information
Report in collaboration with FDA to present a
compatative analysis between ISO 13485:2016 and
the QSR.
III. FDA proposes that any final rule based on this
proposal become effective 1 year after the date of
publication of the final rule in the Federal Register
VII. Timelines And Takeaways
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13. IX. Questions And
Feedback
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14. 1. ISO 13485:2016, “Medical devices—Quality management systems—Requirements for regulatory purposes,” Third Edition,
March 1, 2016.
2. FDA, “Regulations Establishing Good Manufacturing Practices for the Manufacture, Packing, Storage, and Installation of
Medical Devices.” Federal Register , 43: 31508-31532, July 21, 1978.
3. ISO 13485:1996, “Quality systems—Medical devices—Particular requirements for the application of ISO 9001,” December
1996 (withdrawn). (Referenced at: https://www.iso.org/standard/22098.html. )
4. ISO 9001:1994, “Quality Systems—Model for Quality Assurance in Design, Development, Production, Installation, and
Servicing,” June 1994 (withdrawn). (Referenced at: https://www.iso.org/standard/25946.html. )
5. FDA, “Medical Device Single Audit Program (MDSAP).” (Available at: https://www.fda.gov/medical-devices/cdrh-
international-programs/medical-device-single-audit-program-mdsap. )
6. Global Harmonization Task Force. Guidance document, “Implementation of Risk Management Principles and Activities
Within a Quality Management System,” May 20, 2005. (Available at: http://www.imdrf.org/docs/ghtf/final/sg3/technical-
docs/ghtf-sg3-n15r8-risk-management-principles-qms-050520.pdf. )
7. ISO 14971, “Medical Devices—Application of Risk Management to Medical Devices.” (Available at:
https://www.iso.org/standard/72704.html. )
Resource Pages
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15. 8. “Guidance for Industry, Third Parties and Food and Drug Administration Staff: Medical Device ISO 13485:2003 Voluntary
Audit Report Submission Pilot Program” effective June 5, 2012. Federal Register , March 19, 2012 (Available at:
https://www.federalregister.gov/citation/77-FR-16036 ).
9. International Medical Device Regulators Forum, http://www.imdrf.org/.
10. International Standard, ISO 9000 “Quality Management Systems—Fundamentals and Vocabulary,” ISO 9000:2015.
(Available at: ISO 9000:2015(en), Quality management systems—Fundamentals and vocabulary.)
11. “Preliminary Regulatory Impact Analysis, Initial Regulatory Flexibility Analysis, and Unfunded Mandates Reform Act
Analysis; Medical Devices; Quality System Regulation Amendments.” (Available at: https://www.fda.gov/about-
fda/reports/economic-impact-analyses-fda-regulations. )
12. Federal Register :: Medical Devices; Quality System Regulation Amendments
Resource Pages
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