On February 23, 2022 the U.S. Food and Drug Administration (FDA) published the proposed ruling of changes to the current 21 CFR part 820 – Quality System Regulation (QSR) and upon finalization, will be referred to as the ‘Quality Management System Regulation (QMSR).’ This ruling, among other changes, incorporates a significant shift incorporating by reference, the Quality Management System requirements of ISO 13485:2016.
The draft QMSR is currently nine (9) pages in length, demonstrating that the FDA is focused on simplifying and streamlining the regulation to reduce burden on device manufacturers while ensuring the safe and effective manufacture of products.
The FDA recognizes that although the requirements of ISO 13485:2016 are substantially similar to current part 820, there are modifications required to better align with FDA compliance and regulatory requirements. A thorough comparison of the current QSR to ISO 13485 was completed, and a high level comparison of similarities and differences is shared in the proposed ruling. The following is a list of the identified differences from the ruling with just four (4) significant differences noted:
|21 CFR 820||ISO 13485:2016||Proposed Rule|
|Subpart D – Document Controls||Clause 4. – Quality Management System||Differences addressed in 820.35|
|Subpart K – Labeling and Packaging Controls||Clause 7. – Product Realization||Differences addressed in 820.45|
|Subpart M – Records||Clause 4. – Quality Management System||Differences addressed in 820.35|
|Subpart N –Servicing||Clause 7. – Servicing||Differences addresses in 820.35|
The above changes are addressed as follows within the new structure of the proposed QMSR:
PART 820 – QUALITY MANAGEMENT SYSTEM REGULATION
Subpart A – General Provisions
820.7 Incorporation by reference.
820.10 Requirements for quality management system.
820.15 Clarification of concepts.
Subpart B – Supplemental Provisions
820.35 Control of Documents.
820.45 Device labeling and packaging controls.
To highlight a few of the proposed changes:
Definitions (820.3): A variety of changes to Definitions of the 21 CFR part 820 are being proposed. The FDA retains, modifies or clarifies terms that are necessary for the purposes of part 820. The Definitions are clearly documented in the proposed rule.
Clarification of Concepts (820.15): The FDA provides clarifications for three (3) concepts in section 820.15 of the proposed ‘QMSR: Organization, Safety and Performance and Validation of Processes.’ The FDA includes clarification of these ISO 13485 terms to explain how they relate to statutory and regulatory frameworks for medical devices:
- Organization: ISO 13485 uses the term “organization” to describe the entity that is creating a QMS; and the FDA proposes clarification of the term “organization” to include the “manufacturer” as defined in 820.3.
- Safety and Performance: Clarification added to ensure when ‘Safety and Performance’ is used, it means ‘Safety and Effectiveness.’
- Validation of Processes: ISO 13485 uses the term “validation of processes” and the FDA proposes to clarify the term to “process validation,” as that term is defined in part 820.
Control of Records (820.35): Additional proposed requirements to the Control of Records requirements are that records are established and maintained to ensure the validity of records necessary for the FDA. Specifically, the ruling is proposes adding to the following requirement to clause to 4.2.5 of the ISO 13485:2016 standard:
- Manufacturers to obtain a signature for each individual who approves or re-approves records
- Date of approval
- The specific information that must be collected for records addressing complaints and servicing activities to ensure alignment with 21 CFR part 830 and documentation required to meet Unique Device Identification (UDI) for each device or batch of devices.
- Tetaining part 820.180 requirements for identifying records deemed confidential to be identified as such (these requirements can be found in the proposed rule in section 820.35).
Device Labeling and Packaging Controls (820.45): The FDA notes that ISO 13485 does not provide the additional requirements for labeling and packaging, nor addresses the inspection of labeling by the manufacturer. Therefore, the FDA will retain these requirements from the current part 820. In 820.45 of the proposed QMSR, the QSR requirements for labeling inspection activites will be added to Clause 7.5.1 of ISO 13485.
Risk Management: One of the key elements of ISO 13485 that is not explict in part 820 is Risk Management. The FDA acknowledges that although not explictly stated, Risk Management is addressed in the preamble and the intent of the regulation. ISO 13485:2016 approaches risk throughout the QMS and lifecycle of the product, therefore, with the adoptions of ISO 13485, there will be greater emphasis on risk management activities under the QMSR with explicit integration of risk management throughout the requirements and establishing the total product lifecycle.
FDA Device Good Manufacturing Practice (GMP) Advisory Committee Meeting
On Mach 2, 2022, the FDA Device Good Manufacturing Practice Advisory Committee Meeting was held to discuss the proposed changes. The FDA reviewed the changes, committee members shared their thoughts and the public presented their questions and concerns. It is apparent that FDA is keeping to their plan to simplify and streamline the regulations, which NAMSA agrees will provide many benefits, including:
- Promoting global harmonization;
- Harmonizing QMS requirements used by many other international regulatory authorizes whom already recognize ISO 13485:2016;
- Eliminating the need to maintain a QMS in alignment with multiple quality standards and regulations; and
- Reducing the amount of country specific regulatory burden.
Industry appears very welcoming of the proposed ruling and shared their thoughts and perceived benefits of the forthcoming changes. Although, strong support of these changes was evident at the March 2 meeting, there were a few noted concerns shared with and welcomed by FDA, such as:
- Transition Period: In the ruling, the FDA suggested a one (1) year transition once the changes become effective. At the meeting, there were a significant number of requests to lengthen this transition time to either two (2) or even three (3) years. The longer time will give industry time to adapt to the new requirements, especially organizations that currently only sell in the U.S. and are not as familiar with ISO 13485.
- Rollout and Implementation: Several comments were shared regarding the importance of a well-planned and clear roll-out. Not only with established dates, but possible guidance documents for industry to follow, further ensuring a smooth rollout of the regulation.
- FDA Inspections: Several requests were made to not only update the Quality System Inspection (QSIT) guide, but to ensure FDA investigators are well trained. Questions were discussed on inspection style and possible harmonization with audits from Notified Bodies (NBs).
- Risk Management: The comment was made that industry may not be prepared for the greater emphasis on Risk Management and thus, suggested the FDA consider a guidance document for key stakeholders. This is a great suggestion for U.S.-based manufacturers that have not yet embraced ISO 13485, and especially true for medical device suppliers that only have ISO 9001 certification.
- ISO Certification: Since the FDA inspections will not result in the issuance of an ISO 13485 certificate, nor is an ISO 13485 certificate required, the request was made for the FDA to clearly communicate this position.
- Guidance and Training: Many requests were made for guidance and other materials from the FDA to help assist industry in transitioning to the new rule.
The FDA and Advisory Committee thanked all participants for their comments, questions and concerns and noted that they will be taking them all into consideration.
Things are moving forward and look very promising for the proposed QMSR rule. There is a 90-day public comment period prior to subsequent revisions and the FDA welcomes comments through May 24, 2022.
If you haven’t already done so, please look at the proposed ruling and present your comments for review before this timeframe. It is not too early for manufacturers and suppliers to start taking action. NAMSA is committed to helping and supporting manufacturers throughout this transition and recommends the following:
- Familiarize and train your team on the ISO 13485:2016 standard.
- If you have yet to address ISO 13485:2016 within your QMS, now is the time to assess your system and identify gaps.
- Risk Management is integrated throughout ISO 13485:2016—now is the time to familiarize and train your team and possibly complete a Risk Management Gap Assessment to ensure that this area is integrated throughout your QMS and the total product lifecycle.
- Start drafting a Quality Plan for transition your QMS to the new set of requirements.
- Assure that your critical suppliers are aware of the FDA plans and are adjusting their systems to align to your quality system needs.
How Can NAMSA Help?
The criticality of the development, implementation, adherence and continuous improvement of a compliant QMS cannot be overstated. Not only are these key processes in driving company value, but more importantly, they help ensure patient safety and the delivery of high-quality products to those that need them most. NAMSA’s global Quality Consulting Team can assist you to meet the changing QMS landscape head-on while maintaining compliance through:
- Gap Assessments: Complete a full gap assessment to ISO 13485:2016, FDA 21 CFR part 820 and/or the proposed FDA Quality Management System Regulation (QMSR)
- QMS Transition Plans: Assist in the development plan for transition to the QMSR and resolve any identified gaps
- Inspection Readiness: Conduct audits or mock inspections of QMS to applicable standards and regulations
- Risk Management Programs: Review/assess existing procedures, plans, reports and records; develop and implement plans, risk analyses and reports
- Supplier Quality Audits: Audit suppliers for quality compliance to quality standards and regulations
To learn more about NAMSA’s full quality service offerings, please visit: https://namsa.com/services/regulatory/. You may also visit https://namsa.com/namsa-expertise/subject-matter-experts/ to get in touch with our leading quality experts.
Lisa Schwartz joined NAMSA in 2021 as a Principal Quality Consultant and is passionate about helping Clients improve QMS to ensure compliance to quality standards and regulatory requirements. Lisa has over 20 years’ experience in the medical device industry, including developing, implementing and managing Quality Management Systems (QMS) for medical devices start-ups to midsize and global companies. While in industry, she has held various individual contributor and quality leadership roles in Quality Assurance (QA) supporting or overseeing QMS compliance, design, manufacturing, quality engineering, supplier quality and auditing. Other medical device industry experience involves a wide range of products including: implantable devices, single use products and drug coated devices. She also has experience working for a Notified Body as a Lead Auditor, 510(k) Reviewer and Project Manager.