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TGA on IVD Software Uncategorized

TGA on IVD Software

The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices, has published guidance dedicated to software as in vitro diagnostic medical devices. The initial version of the document was published in September 2013....

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FDA eSTAR Pilot Program FDA

FDA eSTAR Pilot Program

The Food and Drugs Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published detailed guidance dedicated to the eSTAR Pilot Program, which is a part of the 510(k) Program Pilots together with the 510(k) Review...

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