FDA
The new article addresses the matters related to data collection and describes in detail different types of information and the ways it could be collected. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating...
FDA
The new article provides a brief overview of the human factors validation testing and also addresses certain specific aspects associated thereto, including the ones related to the test participants. Table of Contents The Food and Drug...
Asia
The first article provides an overview of the general provisions of a new draft regulation on clinical trials for medical devices. Table of Contents The Turkish regulating authority has published a draft regulation on clinical trials for medical devices....
Australia and Oceania
The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the classification of active medical devices (including software-based ones). The document issued in...
