The FDA has released draft guidance (1) stating it will accept “valid” foreign clinical trial data in support of premarket submissions for medical devices to be released in the USA. It turns out they already did – with the proviso that “special considerations” are applied “when using such data, including applicability to populations within the United States and study design issues” – it’s just that their position could have been clearer. So to avoid companies performing “unnecessary duplicate studies” and to “further efforts to harmonize global clinical trial standards, and promote public health and innovation,” they’ve issued this guidance.
References
- Office of the Federal Register, “Acceptance of medical device clinical data from studies conducted outside the United States; draft guidance for industry and food and drug administration staff; availability”, (2015). Available at: http://1.usa.gov/1I4pDX1. Accessed April 24, 2015.
