The two main regulatory bodies, which will need to be consulted during product development, are the Australian Therapeutic Goods Administration (TGA) and the US Food and Drug Administration (FDA).   According to the guidelines from the FDA , any new nanotechnology-based product which spans the regulatory boundaries between pharmaceuticals, medical devices and biologicals will be regulated as a “Combination Product”.   In such cases, FDA will determine the “primary” mode of action of the product         Regulatory approval is therefore anticipated to require completion as appropriate for in vitro diagnostics.  

In vitro diagnostics may be exempt from investigational device requirements if certain conditions are met:

  1. The testing is non-invasive.
  2. Does not require invasive sampling presenting significant risk.
  3. Does not introduce energy into a subject.
  4. Is not used as a diagnostic procedure without confirmation of the diagnosis by another, medically established diagnostic device or procedure (21 CFR 812.2(c)(3)).

BioDetectors approach minimises regulatory exposure, as positive BioDetectors tests will be confirmed by follow-up.


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