After February 21, 2019, new FDA requirements for clinical investigations went into effect. These requirements are intended to ensure clinical data quality and integrity, as well as to protect human subjects’ well-being and safety. As a way of keeping domestic and international premarket medical device submissions consistent for regulatory review, the new acceptance criteria take aim at very particular issues in the compliance process for clinical investigations.
To clarify their position on clinical trial data, FDA released guidance documents on their acceptance criteria and good clinical practice (GCP) back in 2018. Now that the new requirements have officially come into effect, looking at this guidance can bring a number of insights for medical device manufacturers moving forward. We’ve compiled what we believe are seven key takeaways from the guidance, and what they mean for your organization.
Back in February 2018, FDA amended regulations related to how data from clinical investigations of medical devices are accepted. This change was directed at those investigations conducted outside of the United States (OUS) for nearly all submission pathways: 510(k)s, PMAs, De Novos, Humanitarian Device Exemptions, and so on. There is a clear drive from FDA to ensure all OUS clinical data complies with GCP requirements to confirm safety and effectiveness of medical devices.
FDA’s firmness in ensuring GCP requirements are adhered to in clinical investigations is likely a consequence of the rise of multinational clinical trials. Due to cost savings, increasing demand in the global medical device market, fewer regulatory hurdles in setting up trials, or otherwise, more firms are conducting trials OUS than ever before.
While it might seem self-evident, it’s important to note FDA’s insistence on being able to find information required for GCP compliance in your device submission. Regulators expect that claims in the compliance statements are supported by data contained within the submission deliverables for any premarket notification center. Having that information accessible streamlines review timelines and provides your own organization clarity about your compliance efforts too.
Additionally, descriptions of these sites need to be part of the clinical data you submit to FDA. Especially because the agency is less likely to be familiar with OUS facilities, it’s critical to include plenty of detail in the submission.
Valid scientific evidence is the backbone of FDA’s decision to accept or reject the results of clinical investigations. However, variations in the evidence generated can occur, and can be influenced by everything from usability factors (experience, device-user interface, etc.) to technological characteristics. These are also impacted by cultural and economic differences between US and OUS sites. Because of all these variations, clinical results gathered at an OUS site might be seen by reviewers as misaligned with US populations and healthcare. Therefore, FDA recommends that submitters include statements related to applicability of clinical investigation findings to US markets.