FDA
The Food and Drug Administration (FDA), the US regulating authority, has published guidance describing technical considerations for non-clinical assessment of medical devices containing nitinol. The present document constitutes a final version of the draft guidance...
FDA
The Food and Drug Administration (FDA) has published an enforcement policy for modifications to FDA-cleared molecular influenza and RSV tests in the context of the outbreak of the COVID-19, and the public health emergency associated thereto. Important notes Due to the...
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The Taiwan Food and Drug Administration (FDA) has published several draft guidance documents dedicated to the post-market activities related to medical devices marketed in Taiwan.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...
Saudi Arabia
The Saudi Food and Drug Authority (SFDA), the country’s regulating authority, has published a guidance document dedicated to the requirements for electronic instructions for use (eIFU) of medical devices. The document was initially published on August 22, 2019, for...
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