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A year into FDA’s Expedited Access Pathway program, the agency has made 29 decisions on requests — accepting 17 and denying 12 — with review decisions usually made in 30 days. Read More
Inner Mongolia has created a framework to establish an independent FDA in an effort to monitor the safety and efficacy of products sold within the territory. Read More
General Devices, a maker of mobile telemedicine systems, has been warned for not finding the root causes of problems or documenting complaint evaluations. Read More
FDA is outlining how manufacturers should share patient-specific information derived from medical devices used to treat or diagnose patients. Read More
The World Health Organization has published a model regulatory guidance for medical devices and IVDs intended to support developing nations that have yet to develop regulations covering medical devices. Read More
The European Commission has published an updated version of harmonized standards that devicemakers and diagnostics makers can reference to ensure their products comply with relevant EU legislation. Read More
Australia’s TGA is cautioning healthcare providers that Zimmer’s Trabecular metal knee implant may contain non-sterile implant components that could result in post-operative infection. Read More