• Melita Ball

FDA QSR-ISO Merge - How Will It Work for You?

FDA QSR-ISO Merge - Is it Good for You?

Today, we continue our discussion from last week’s article around the FDA’s announcement to supplant the existing US Quality System Regulation requirements with those of ISO 13485:2016. If you missed the first blog in the series, you can read it here.

Let me be clear that the goal of this series of blogs is not to debate whether the Standard is somehow better or worse than the existing Quality System Regulation. My goal is to explore why the FDA thinks that adopting the ISO 13485:2016 Standard will somehow magically REDUCE the existing “compliance and recordkeeping burdens” for US companies when the new version of the Standard and the US FDA Quality System Regulation are already harmonized more than ever before.

I’ll start with a discussion of two points related to the respective content of both 21 CFR Part 820 and ISO 13485:2016. Then, we will explore how design controls for some US small device companies could be negatively impacted.

First, most of us agree that the new version of ISO (2016) was the best attempt so far at truly harmonizing the Standard and US FDA QMS requirements. In fact, the language in the new version of the Standard is largely the same as (or very close to) the existing US Quality System Regulation in most areas. Consequently, the recordkeeping requirements and compliance burdens are also well harmonized.

Second, the impact of the new version of ISO 13485 was felt not just in EU device companies that previously didn’t distribute devices into the US but also by US companies that distribute devices into the EU, that, in theory, should have already been compliant to both. Why? Because where there are still differences, the changes implemented in the Standard are actually more burdensome than the existing FDA requirements. A good example is the differences between the definition of “product.” The FDA’s definition is much narrower than the definition put forward in the Standard. Since recordkeeping requirements are directly related to what is considered “product” in both the Standard and the US QSR, the Standard actually requires more comprehensive recordkeeping than the existing FDA requirements do.

Let’s look at one more specific barrier to think about …

US companies that currently only distribute devices in the US and, therefore, only have to be concerned about complying with 21 CFR Part 820 will be forced to adopt ISO 13485:2016. Aside from the addition of the already more burdensome requirements listed in ISO 13485:2016, there’s another difference related to Design Controls. The US FDA design control requirements only apply to class III and class II devices and a very short list of class I devices.

The Standard has no such exemption and all device companies must comply with Design Control recordkeeping requirements. Since ISO 13485:2016 adopted most of the language from the FDA Design Control requirements in 2016, the Standard already contains the significant recordkeeping burdens from the FDA related to design. The difference is that the FDA currently limits the scope of those burdens and the Standard does not. Hundreds of small low-risk device companies in the US will now be strapped with significant compliance and recordkeeping burdens that they do not currently have. These extra burdens carry more cost and could easily put these companies out of business.

Stay tuned for our next blog where I’ll tease out some of the barriers related to how US diagnostic companies may be negatively impacted by the FDAs announcement. We will specifically look at how in vitro Diagnostics (IVD), Lab Developed Tests (LDT), and Analyte Specific Reagents (ASR) are currently handled differently in the Quality System Regulation than they are in the ISO Standards.

Thoughts? Please comment below …

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