The regulation of nutrigenetic tests in Australia

3 December 2010

Disclaimer

This document is intended as a guide only. It should not be relied upon to address every aspect of relevant legislation. Please refer to the Therapeutic Goods Act 1989 (the Act) and the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations) for current legislative requirements. The TGA is not liable for any loss whatsoever whether due to negligence or otherwise arising from the use of or reliance on this document.

Further information

For general enquiries relating to in vitro diagnostic devices (IVDs) contact the TGA Devices Authorisation Branch, IVD Assessment Section, at:

Telephone: 1800 141 144 (freecall)

  • Users who are deaf or have a hearing or speech impairment can call through the National Relay Service:
    • TTY or computer with modem users phone 1800 555 677 then ask for 1800 020 653
    • Speak and listen (speech to speech relay) users phone 1800 555 727 then ask for 1800 020 653

Facsimile: 02 6232 8299

Email: cab.medical.device.information@tga.gov.au

Website: IVD medical devices regulation basics

Post: Devices Authorisation Branch, PO Box 100, Woden ACT 2606, Australia

Background

Nutritional genomics is a science studying the relationship between the human genome, nutrition and health. It can be divided into two subcategories:

  1. Nutrigenomics: studies the effect of nutrients on the genome at the molecular, cellular and systemic levels.
  2. Nutrigenetics: studies the effect of genetic variations on the interaction between diet and health, with implications to susceptible subgroups.1

The field of nutrigenetics provides the basis for personalised dietary recommendations based on an individual's genetic makeup, in order to prevent common multifactorial disorders decades before their clinical manifestation. The potential to change the future of dietary guidelines and personal diet recommendations is fuelled by an increasing number of sophisticated molecular techniques available for interrogating the human genome.

Practical applications arising from the science of nutritional genomics must be supported by stringent validation of any claims. As a consequence, a personalised approach to medicine using tools such as nutrigenetics is beginning to be explored, but requires much more clinical and translational research before it is broadly accepted.

In this document, the term "nutrigenetic tests" is used and is intended to encompass all nutritional genomic assays that fall under the definition of a therapeutic good.

1 Ordovas JM, Mooser V, Nutrigenomics and nutrigenetics, Curr Opin Lipidol, 2004 Apr;15(2):101-8.

Regulation of nutrigenetic tests in Australia

Dependant upon the claims made by the manufacturer of each test, nutrigenetic tests are considered to be therapeutic goods and therefore must comply with the requirements of the Act.

The Act broadly defines a 'therapeutic good' as a good which is represented in any way to be, or is likely to be taken to be, for therapeutic use (unless specifically excluded or included under Section 7 of the Act).

Therapeutic use means use in or in connection with:

  • preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury;
  • influencing, inhibiting or modifying a physiological process;
  • testing the susceptibility of persons to a disease or ailment;
  • influencing, controlling or preventing conception;
  • testing for pregnancy; or
  • replacement or modification of parts of the anatomy.

Any nutrigenetic tests that are intended to be used or that are marketed for their potential to influence a physiological process, will be required to fulfil current regulatory requirements.

Regulatory requirements for nutrigenetic tests

Amendments to the Therapeutic Goods (Medical Devices) Regulations 2002 covering IVDs commenced on 1 July 2010. Nutrigenetic tests are regulated under the new IVD framework.

The definition of an IVD in the new Regulations is:

IVD medical device, or in vitro diagnostic medical device, means a medical device that is:

  1. a reagent, calibrator, control material, kit, specimen receptacle, software, instrument, apparatus, equipment or system, whether used alone or in combination with another diagnostic product for in vitro use; and
  2. intended by the manufacturer to be used in vitro for the examination of a specimen derived from the human body, solely or principally for:
    1. giving information about a physiological or pathological state or a congenital abnormality; or
    2. determining safety and compatibility with a potential recipient; or
    3. monitoring therapeutic measures; and
  3. not a product that is:
    1. intended for general laboratory use; and
    2. not manufactured, sold or presented for use as an IVD medical device.

Some key elements of the new IVD framework are:

  • All IVDs must be manufactured in a manner to ensure safety, quality and performance is apparent at all times when used according to the manufacturer's intended purpose.
  • Regulatory oversight will be commensurate with the level of risk the use of the IVD poses to the health of an individual or the public. This is achieved by the manufacturer classifying each IVD according to a set of risk based rules into 4 classes (Classes 1-4) with IVDs classified as Class 4 having the highest regulatory oversight.
  • The classification rules are prescribed in the Regulations as follows:
    • Class 4 IVDs - High public health risk
    • Class 3 IVDs - Moderate public health risk or high personal risk
    • Class 2 IVDs - Low public health risk or moderate personal risk
    • Class 1 IVDs - No public health risk or low personal risk
  • The new framework includes the regulation of IVDs produced commercially and produced "in-house". The definition of an in-house IVD in the Regulations is:

    in-house IVD medical device means an IVD medical device that is:
    1. within the confines or scope of an Australian medical laboratory or Australian medical laboratory network:
      1. developed from first principles; or
      2. developed or modified from a published source; or
      3. developed or modified from any other source; or
      4. used for a purpose, other than the intended purpose assigned by the manufacturer; and
    2. not supplied for use outside that medical laboratory or medical laboratory network.
  • In response to concerns raised by professional bodies and Australian governments, the legislation prohibits supply of self testing IVDs for serious disease markers. These are set out in the Therapeutic Goods (Excluded purposes) Specification 2010 which can be found on ComLaw. Self-testing IVDs for genetic testing to determine the presence of, or predict susceptibility to, diseases in humans are excluded under this Specification except where the device is also to be used for any of the following purposes:
    1. for testing for a disease or condition as part of a public health screening program sponsored by the government of the Commonwealth or a State or Territory;
    2. for self-testing to monitor a diagnosed disease or condition;
    3. for export only
  • Key aspects of the IVD regulations in relation to nutrigenetic tests are:
    • Most nutrigenetic tests will be classified as Class 3 IVDs. They are required to be included in the ARTG, and the manufacturer must hold evidence of compliance with the Essential Principles, as described in the Regulations.
    • Access to nutrigenetic assays that are for self testing or home use to determine the presence of, or predict susceptibility to, diseases in humans are excluded from entry in the ARTG.
    • Commercial manufacturers must have in place a Quality Management System for manufacture. The accepted QMS standard is ISO 13485: 2003 Medical devices - Quality management systems - Requirements for regulatory purposes. For more details of the requirements for manufacturer's evidence under the new IVD framework refer to the Regulatory guidelines & standards for medical devices.
    • Many nutrigenetic tests are developed by laboratories as "in-house" tests. In these cases, the regulatory requirements must be demonstrated by compliance with Part 6A, Schedule 3 of the Regulations. Compliance primarily requires:
      • Maintaining accreditation as a medical testing laboratory by the National Association of Testing Authorities, Australia (NATA) that includes all nutrigenetic assays in the scope of the accreditation; and
      • Manufacture of the in-house IVDs that meets the National Pathology Accreditation Advisory Council performance standard Requirements for the Development and Use of In-house In Vitro Diagnostic Devices (IVDs).
  • All manufacturers of nutrigenetic tests must hold sufficient data to support all analytical and clinical claims made regarding the product. The requirements for clinical evidence are prescribed in Part 8, Schedule 3 of the Regulations.
  • The above requirements will provide assurance that the IVDs are made using quality systems for ongoing quality, safety and performance. The quality system approach relies on control of processes using quality assurance controls both during production and during use.
  • Commercial and in-house manufacturers must have systems in place to ensure ongoing quality in the post market phase.
    • Manufacturers and sponsors will be obliged to report any serious adverse events to the TGA for further investigation.
    • Manufacturers, sponsors and users of genetic tests are encouraged to report to the TGA any occasions where the quality, safety or performance of a genetic test is in doubt, when used according to the intended purpose.