November 24, 2015
Your Foreign Clinical Data: Does FDA Love It? Or does it not?
We’ve been telling our clients for a while that their medical device studies outside of USA (‘foreign’) can very well be used for FDA ‘acceptance’. You should keep some important things in mind but it is certainly doable (and probably faster as well as cheaper…)
In first half of 2015 FDA issued a new draft guidance titled “Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States – Draft Guidance for Industry and Food and Drug Administration Staff” (aka the “Foreign Study Data Guidance”). This guidance applies to medical device manufacturers when initiating a foreign study for data or relying on previously collected data from a foreign study to support an (“IDE”), premarket notification (“510(k)”), de novo petition (“de novo”), Humanitarian Device Exemption (“HDE”), or premarket approval application (“PMA”).
But why should you believe us? See below the Client alert from June 2015 from DuVal & Associates, a boutique law firm located in Minneapolis, Minnesota, USA. (published with permission)
Clients often come to our firm asking, “Will FDA accept our foreign clinical data?” In years past, our answer was an equivocal “yes” which required explanation. Today, FDA has unequivocally opened up to foreign data, but will not drop its expectation that the data be developed, monitored and reported in a robust, American-like fashion. FDA has, after all, been skeptical of foreign data due to the lack of rigor it has seen in foreign studies in the past. Our firm certainly has seen its share of foreign data that has not measured up to that typically seen in the United States, but it has gotten much better. This Client Alert addresses FDA’s recent guidance on the topic of the acceptance of foreign data by FDA. In late April, 2015, FDA issued a new draft guidance titled “Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States – Draft Guidance for Industry and Food and Drug Administration Staff” (the “Foreign Study Data Guidance”).
In this new draft guidance document, FDA acknowledges that as clinical research becomes more and more globalized, certain challenges arise when using foreign clinical study data to support a device premarket application. Differences in study populations, clinical care, and treatment options are just a few of these challenges. FDA could find such differences render the data inapplicable to the intended US populations and ultimately reject it. To avoid that result, FDA has issued this guidance to describe how it evaluates whether certain aspects of foreign study data are adequate for a premarket application. This Client Alert highlights these aspects and discusses what sponsors can do to ensure their foreign study data is applicable.
Scope of the Draft Guidance
The Foreign Study Data Guidance applies to medical device manufacturers when initiating a foreign study for data or relying on previously collected data from a foreign study to support an (“IDE”), premarket notification (“510(k)”), de novo petition (“de novo”), Humanitarian Device Exemption (“HDE”), or premarket approval application (“PMA”).
Framework for FDA’s Acceptance of Clinical Trial Data
FDA regulation requires that most premarket applications be supported by valid scientific evidence. The Foreign Study Data Guidance echoes this same standards in regards to foreign data. According to the regulation, valid scientific evidence is:
“evidence from well‐controlled investigations, partially controlled studies, studies and objective trials without matched controls, well‐documented case histories conducted by qualified experts, and reports of significant human experience with a marketed device, from which it can fairly and responsibly be concluded by qualified experts that there is reasonable assurance of the safety and effectiveness of a device under its conditions of use.”
It is important to note that current FDA regulations addressing foreign study data only apply to PMA applications; there are no current regulations addressing IDEs, 510(k)s, de novos or HDEs. Despite the absence of such regulation, FDA has had a longstanding approach of accepting scientifically valid data, regardless of where the study was conducted. Moreover, the Food and Drug Administration Safety and Innovation Act of 2012 (“FDASIA”) codified this position regarding the use of foreign clinical study data.
The current regulation regarding foreign study data for PMA applications is outlined below, followed by the most recent FDASIA provision that covers any device application.
You can read the full client alert here.
For more information on DuVal & Associates visit their website at www.duvalfdalaw.com or call Mark DuVal for a consult at +16123387170 x1.