RegDesk News/Info Sometimes, managing medical device submissions can feel like dating in high school- lots of rejection. In an industry where regulatory compliance comes with the highest stakes, it’s surprising that failure to comply with submission requirements is so...
Australia and Oceania The Therapeutic Goods Administration (TGA), the Australian authority responsible for regulations in the sphere of healthcare products, has published guidance dedicated to auditing medical device applications. The scope of the document covers not only general medical...
FDA The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has developed a guidance document dedicated to Pre-Requests for Designation (Pre-RFD). The document describes the approach to be applied by...
FDA The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices and other healthcare products, has published a guidance document describing how to write a Request for Designation (RFD). The document is intended to...
FDA The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published detailed guidance dedicated to the types of communication during the review of medical device submissions. The document is intended to...
