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FDA commissioner Scott Gottlieb recently announced a pre-certification pilot programme that aims to speed up the approval process for medical software companies and products that are deemed less risky than traditional medical devices. He stated that through the Pre-Cert for Software Pilot, the FDA seeks to develop "a new and pragmatic approach to digital health technology" that takes into account "the unique characteristics of digital health products and the marketplace for these tools."TheNEXT ARTICLE
In order to become availible to pateints, drugs need to undergo a number of phases of clinical trials to test their efficacy and safty and to then be authorised by the drug approval organistion in each respective country. This is the FDA in the USA and N...