Home News & Events News overview One Medical Device Trial Fits All! ISO 14155 as a Standard for Your Foreign Data Submitted to the FDA

Anne Leijsen

Head of Medical Writing & Senior Clinical Research Associate

February 27, 2018

One Medical Device Trial Fits All! ISO 14155 as a Standard for Your Foreign Data Submitted to the FDA

There is interesting news in the medical device world that may impact your clinical strategy! On February 21, 2018, the FDA released its final ruling on the acceptance of data from clinical investigations for medical devices. With this amendment to the original draft document (“Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States” published in 2015, now withdrawn), the FDA clearly outlines the requirements with respect to data gathered in clinical investigations outside the U.S. And that’s something that we should value – as we stated back in 2015.

Timelines

First of all, we would like to assure you that there is no need to rush into anything. The rule will not go into effect until February 21, 2019, and the requirements that are outlined in the federal register are not overly burdensome. You will have time to review the new rule, analyze whether the requirements apply to your medical device regulatory strategy, and adapt your submission package to the FDA accordingly. We do recommend, however, that you understand the opportunities for your clinical strategy now. The positive impact of the amendment is significant and in-depth knowledge on this topic can certainly work to your advantage. Factory CRO has done the initial work for you, and we are happy to help you to develop a comprehensive clinical plan.

Implications

The most important implication of this amendment is that with this ruling, the FDA formally opens the path to submit foreign clinical data to secure marketing clearance for medical devices in the U.S. Under the draft guidance of 2015, the FDA already accepted such data. However, it was always a topic of debate whether it was the ‘safe’ to choose this pathway.  After all, it would be disastrous to find out that your study does not provide meaningful data for U.S. market access, just because the study was conducted outside the U.S. It is extremely helpful that the FDA has now made their requirements very clear, since the regulatory pathway in e.g. Europe is relatively fast and studies may be performed at considerably lower costs then when performed in the U.S.  With this official ruling, the path is cleared to submit foreign data, as long as the data has been obtained by Good Clinical Practice (GCP).

And this brings us to the next major implication. In the responses to the comments to the amendment, the FDA mentions several times that the FDA recognizes the ISO 14155:2011 as a GCP standard for medical device trials conducted outside the U.S. This confirmation is essential, as the ISO 14155:2011 is a standard that is commonly, and safe to say standardly, used for medical device studies conducted in Europe. The clear recognition of this standard makes it possible for manufacturers to conduct their studies in a manner expected by local laws – without extra regulations imposed by the FDA.

The FDA has been asked why they choose the language “by Good Clinical Practice” in the final rule, in contrast to the ICH E6 and ISO 14155:2011 that use the term “by principles of Good Clinical Practice”. The FDA explained that the currently used terminology should eliminate potential misinterpretation. The sponsor or applicant shall indicate conformity with a specific GCP standard in a statement that is to be provided to the FDA – in this manner it is covered which principles are being used for the definition of Good Clinical Practice. Response 22 

Good Clinical Practice

It is no problem if you have already conducted your study outside the U.S. and you did not work according to the ISO 14155:2011 standard. The amendment not only accepts this standard but keeps the statement broad confirming that a study must be performed according to GCP – and acknowledges that national requirements may have other guidelines or standards. The FDA does have a definition for GCP, namely: “a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical investigations in a way that provides assurance that the data and results are credible and accurate and that the rights, safety, and well-being of subjects are protected”. This is a broad definition that we agree to be essential in any clinical investigation that you may perform.

What’s Next?

The time is now to think bigger than just the U.S. when conducting your clinical investigations. There are many possibilities available, given that you now have access to a whole new pool of investigators and subjects, that could lead to faster patient recruitment in combination with lower costs. Whether it is a clinical investigation conducted exclusively in Europe, or a multinational study in the U.S., Australia, Europe and Asia, it’s all possible and can lead to successful marketing clearance in the U.S.!

Factory CRO is a full service, global clinical research organization with headquarters in The Netherlands and the U.S., experienced with ISO 14155:2011 standards and requirements, as well as FDA expectations and regulations. Please contact us so that we can help you develop your global clinical development strategy.

About the author

Anne Leijsen Head of Medical Writing & Senior Clinical Research Associate

At Factory CRO, Anne is leading the medical writing team. Anne's expertise lies with Clinical Evaluations. At the same time, she has a special interest in ongoing changes in the medical device guidelines, directives and regulations in both the United States and Europe.

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