FDA
The Food and Drugs Administration (FDA) has published guidance on glucose monitoring systems intended to be used in healthcare facilities (point-care-use). The document constitutes a final version of the guidance issued previously by the Agency in November 2018. It is...
Asia
The Taiwan Food and Drug Administration (FDA) has published several draft guidance documents dedicated to the post-market activities related to medical devices marketed in Taiwan. In particular, the documents are covering the aspects related to the adverse events...
FDA
The Food and Drug Administration (FDA) has published a guidance document dedicated to the basic safety and essential performance of medical electrical equipment, medical electrical systems, and laboratory medical equipment. The document provides the standards-specific...
FDA
The Taiwan Food and Drug Administration (FDA) has published technical guidelines for medical device software inspection and registration of Artificial Intelligence and Machine Learning technology. The new approach is based on the regulations adopted in the United...
FDA
The Food and Drug Administration (FDA), the US regulating authority in the sphere of medical devices and other healthcare products, announced the new improvements and amendments to the Software Precertification Pilot Program. FDA Pre-Cert Pilot Program in Brief...
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