Regulatory frameworks

Having identified some key regulatory challenges, existing regulatory mechanisms that might address these challenges, specifically regulatory frameworks in Europe and North America for medical devices and clinical laboratories are now described. The assumption is that these regulations cover nutrigenetic tests. There has been some doubt about this issue, at least in the UK, with the regulatory body for in vitro diagnostic (IVD) tests, the Medicines and Healthcare Products Agency (MHRA), claiming that because so-called 'lifestyle' tests are not clinical tests, they would not be covered by the relevant legislation (Human Genetics Commission, 2007). The term 'lifestyle test' is not precisely defined, but is sometimes used to describe nutrigenetic tests where the intent is to provide lifestyle advice such as dietary guidance. The MHRA draws a distinction between these and what it deems 'tests for a medical purpose'.

What constitutes an IVD medical device is an important issue. In Europe, a medical device is an item 'intended by the manufacturer to be used for human beings, for the purpose of____diagnosis, prevention, monitoring, treatment or alleviation of disease' (European Commission, 1993) and the definition of an 'in vitro diagnostic medical device' is any medical device which is '... intended by the manufacturer to be used in vitro for the examination of specimens... derived from the human body, solely or principally for the purpose of providing information: concerning a physiological or pathological state ...' (European Commission, 1998).

The Human Genetics Commission (HGC) has questioned the MHRA's position and suggests that 'lifestyle' tests may be considered IVD devices if their purpose is to help in the prevention of disease (Human Genetics Commission, 2007). Moreover, a number of regulatory authorities have indicated they agree with the HGC. At a congressional hearing largely devoted to the regulation of nutrigenetic tests, Steve Gutman, Director of the US Food and Drug Administration's (FDA) Office of In Vitro Diagnostics, answered in the affirmative when asked whether such tests were covered by FDA's regulations for medical devices (US Congress, 2006). Letters were subsequently sent to a number of nutrigenetics companies inviting them to meet with the FDA. In Australia, the Therapeutic Goods Administration (2007) has issued guidance on nutrigenetic tests.

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