The Merger of ISO 13485 and FDA QSR 21 CFR 820 for Medical Devices – Proposed Changes and Implications
Blog | April 4th, 2022

The Merger of ISO 13485 and FDA QSR 21 CFR 820 for Medical Devices – Proposed Changes and Implications

In 2018, the US FDA had announced its plans to harmonize FDA Quality System Regulations (QSR) with ISO 13485:2016 quality system requirements for medical device registrants. This initiative was proposed to increase the alignment of the US market’s pathway more closely with other major device markets.

Taking it a step forward, in 2022, the FDA announced the proposed rule for aligning the current good manufacturing practice (cGMP) requirements of the QSR with ISO 13485:2016. This will further the cause of harmonization, though it will also introduce new challenges.

The Benefits of Harmonization

ISO 13485 is an international standard that the medical devices companies with a global presence are already compliant with. For the US market, they had an additional requirement of being compliant with the FDA’s QSR. By harmonizing the QSR with the ISO requirement, the FDA is attempting to eliminate the duplicative regulatory requirement that acts as an impediment to market access.

For medical device Quality Management Systems, ISO 13485 is a comprehensive standard that elucidates the best practices to be followed to ensure medical device product safety and quality. By aligning with this standard that is de facto in the rest of the world, FDA will pave the way for greater efficiency in the medical device manufacturing companies without compromising on quality.

The Proposed Changes

As part of the proposal, there will be changes to FDA Part 820. While some existing rules will be removed, some new rules drawn from the ISO 13485 will be added. The new additions to Part 820 include:

  • Section 820.7 – Incorporation by reference
  • Section 820.10 – Requirements for a quality management system
  • Section 820.15 – Clarification of concepts
  • Section 820.35 – Control of records
  • Section 820.45 – Device labeling and packaging controls

These additions draw heavily from ISO 13485 to ensure as close an alignment as possible. Among the additions, Section 820.45 will be of special significance since the FDA has elaborated in great detail the requirements for labeling and packaging.

Every year, improper labeling and packaging have been found to be one of the major causes of a large number of device recalls. For instance, in Q3 of 2021, 36 device recalls were due to mislabeling issues. This came in second after software issues.

Since ISO 13485 requirements for inspection of packaging and labeling seem to be insufficient to meet quality needs, FDA has introduced Section 820.45 supplement ISO 13485:2016 in this aspect.

Implications for Medical Device Manufacturers

The medical device industry will have to transition to the new QSR, but the good news is that FDA is giving a year for the transition after the regulations are finalized. The industry representatives have sought a two-year transition period, the decision on which is still pending . During this period, the US-only companies will have to familiarize themselves with ISO 13485:2016.

According to a Preliminary Regulatory Impact Analysis done by the FDA for this proposed rule, nearly 4,445 companies currently are not compliant with ISO 13485. While this may seem like a redundant regulatory step for such companies, compliance with the new regulation and harmonization will make globalization much easier at a later stage.

Implications for Inspectors

FDA uses the Quality System Inspection Technique (QSIT) to inspect medical device companies. Apart from the medical device manufacturers, the FDA is also introducing changes to how inspection of these companies will be regulated, aligning it with the ISO 13485 standard. There will be time given for this transition as well, giving inspectors time to make themselves familiar with ISO 13485.

While FDA will not be issuing ISO 13485 certifications, such a certification will not exempt a company from inspections. Inspection techniques will have to evolve to meet the new requirements. As of now, the rules are still in the proposal stage and will likely undergo many changes before they are firmed up and introduced. But in the meantime, manufacturers should invest time and effort to understand the likely impact of ISO 13485 on the QMS.

As technologies evolve, so do regulations to keep pace. Compliance is only one aspect of these regulations. By improving the processes to comply with the new regulatory needs, businesses can also ensure the development of quality medical devices. The harmonization with global standards will help medical device manufacturers with complying with global standards with ease, establish a global presence with fewer hassles, and improve the speed of alignment at lesser effort, cost and time.

ComplianceQuest EQMS for a Smooth Transition to Meet New Regulatory Requirements

It is too premature to talk about changing the quality management system of your organization to meet the proposed changes. However, automated quality management systems such as the one from ComplianceQuest can make the process smooth, easy, and efficient. The ComplianceQuest cloud-based EQMS is already aligned with the ISO standards. It also enables introducing global changes with simple customization capabilities.

As a result, the transition to a new system will become simpler, seamless, and applicable across the organization in different geographic locations.

Change management is a critical feature of the CQ solution that enables managing changes for a smooth transition. Inspection management can help schedule inspections, implement the new rules, and make businesses inspection ready. Document management will be another key aspect in handling the transition, documenting processes, making them easily accessible at the time of inspections, and submitting regulatory reports. Managing these aspects manually or using a legacy system will be inefficient and counterproductive.

Be future-ready with the cloud-based flexible and scalable EQMS from ComplianceQuest and meet regulatory requirements and changes with the least disruption to business processes. To know more about the CQ solution, visit:

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