The FDA’s proposed rule to align its quality system regulation with ISO 13485 has the industry buzzing. What does it mean for medical device and IVD manufacturers? Let’s take a closer look at the proposed changes and what they might mean for manufacturers if they are adopted.

What is ISO 13485?

ISO 13485 is a quality management system (QMS) standard that was originally published in 1996 and has been recognized and used globally, driven by EU and Canada requirements. Meanwhile, the U.S. has always maintained its own regulation under 21 CFR 820. However, the Food and Drug Administration (FDA) has been working toward harmonization since 2006 with the Medical Device Single Audit Program (MDSAP) and its precursor programs. This harmonization is the culmination of many years of work for the FDA.

In 2018, the FDA announced its intention to align with ISO 13485, and in March 2022, the proposed rule was announced in the Federal Register and followed by a Device Good Manufacturing Practice Advisory Committee meeting. The FDA plans to retain many of the definitions in the current regulation but will make some changes to ensure that the incorporation of ISO 13485 doesn’t create inconsistencies across other FDA medical device regulations. Manufacturers can also expect to see some FDA-specific supplementary provisions that are not covered in ISO 13485.

How is ISO 13485 different from the current FDA regulation?

ISO 13485 was most recently updated in 2016, and 21 CFR 820 has remained largely unchanged since 1996, with design controls added in 1997 representing the most significant change over that time. Although they have been developed separately,  there is a lot of overlap, and the FDA has outlined the expected similarities and differences between the two.

Similarities Between ISO 13485 and FDA Regulations

Generally speaking, the intent is the same in that you want to make sure that you have controls in place to ensure that devices are safe and work properly. The scope of the requirement is fundamentally unchanged, although the details of the specific requirements may be different. Expectations for risk management to begin early in the design process and be integrated with the QMS also remain in place.

Differences Between ISO 13485 and FDA Regulations

The FDA is retaining or modifying some definitions that do not appear in ISO 13485 because they are necessary for alignment with the Federal Food, Drug, & Cosmetic Act, but these changes do not have a significant impact on the spirit of the regulation. One of the more significant changes is around risk management. There will be greater emphasis on risk management; the proposed rule includes explicit integration of risk management through the entire product lifecycle. Furthermore, the proposed rule expands the traceability requirements of ISO 13485 to include not only implantable devices but also devices that support or sustain life.

The FDA-specific supplementary provisions that are not in ISO 13485 include:

  • Control of records, including signature and date requirements, complaint and servicing activities, UDI requirements, and confidentiality
  • Controls for device labeling and packaging, which retains requirements from the quality system regulation and labeling inspection

What is the timeline for implementation?

The public comments stage ended on 24 May 2022. The FDA must then review all comments and make revisions before issuing the final rule. The FDA includes a discussion of the significant comments received in the preamble of the final rule. Given this timeline, the new regulation could be adopted as soon as the end of 2022, but more realistically, it will be adopted in 2023. 

Even after the final rule is issued, there may be an effective or compliance date established in the future that’s not immediately in effect at the time of issuance. This is currently under negotiation, but the FDA’s proposed rule has a one-year implementation time, whereas the industry is requesting a longer implementation time. 

Realistically, a one-year implementation time seems very short, not just for industry but also for the FDA. The FDA will need to retrain its staff, update affected guidance documents, and release new guidance for industry. This will all be necessary to ensure a smooth transition and implementation of the new rule.

How will the adoption of ISO impact manufacturers?

Depending on their existing quality systems, manufacturers can expect a number of changes with the adoption of the new FDA medical device regulation. 

Streamlined Record Keeping

One of the benefits of harmonizing with ISO standards is that it gives manufacturers an opportunity to streamline record keeping. Manufacturers can now produce device records that will comply with ISO without requiring duplication into separate U.S./EU document packages.

Documentation Updates 

Many manufacturers have referenced ISO 13485 and CFR 820 throughout documentation in quality management systems and internal audit programs, and all of these references will need to be updated across all processes. This will likely require cross-functional teams to update the entire document set. To do this successfully, leaders must be involved, and management responsibilities must be aligned across teams. 

ISO 13485 Compliance

Manufacturers will officially have to maintain compliance with ISO 13485, which could require additional resources, especially for manufacturers that do not yet have ISO 13485 in place. No third-party certification is required, but compliance will be mandatory. Manufacturers that already participate in MDSAP will have a head start because those audits are already based on ISO 13485 standards. 

Changes in Risk Management

Risk management will get increased attention in inspections because ISO 13485 defines it in more detail. Manufacturers will therefore need to be compliant with ISO 14971 in order to satisfy requirements. This is particularly important for manufacturers with software as medical devices (SaMD) because it will be more difficult to achieve risk management compliance.

When should manufacturers start implementation?

The proposed rule is not yet in effect, and it’s possible there will be changes based on industry feedback before it is finalized. Manufacturers need to find the balance between making changes now and waiting for the final rule. Some of the advantages of getting started now include:

  • The sooner you start, the more time you will have.
  • It may be easier to make incremental changes over time.
  • You can incorporate changes as you’re touching documents, rather than having to go back over them a second time.

If you don’t already have a quality management system that is compliant with ISO 13485, it makes sense to begin the process of bringing your quality system into alignment with the standard because it is unlikely that the fundamental principles will be different. If you do have a quality system that is compliant with ISO 13485, it might make sense to wait until the regulation is published—especially if implementation times get pushed out a little longer.

What is unknown?

Although the announcement of the proposed rule is a big step forward, there are still a lot of unresolved questions, such as:

  • What changes will still be made to the proposed rule?
  • How will ISO 13485 certifications factor into the FDA’s evaluations?
  • What will the new Quality System Inspection Technique (QSIT) model look like?
  • How will the FDA be able to stay aligned to ISO 13485 as newer versions are released?
  • How will changes affect premarket submissions involving QMS review? 

It’s clear that many things still need to be hammered out before this proposed rule can be finalized and effectively implemented, so watch this space!

How does RQM+ help?

Every change in FDA medical device regulation should be viewed as an opportunity to streamline and gain efficiency. Ultimately, your quality system will mature and reach the next level, making every day easier. RQM+ can help you get to this next level with a range of FDA solutions, including:

  • Implementing quality systems
  • Performing third-party audits
  • Updating quality system procedures
  • Facilitating redesign of record keeping associated with devices
  • Helping manufacturers streamline processes

Regulatory changes always come with challenges. The expert team at RQM+ is used to adapting to the global regulatory landscape and helping manufacturers do the same efficiently and with business-balanced solutions. 

Check out our RQM+ Live! show, “When should we throw the least burdensome flag or appeal an FDA decision?” to learn more about how we can help you navigate interactions with the FDA.

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