Oct 7, 2020
FDA
The Food and Drug Administration (FDA) has published guidance dedicated to the self-monitoring blood glucose test systems intended for over-the-counter use. Important Notes The document represents a final version of the document issued previously in November 2018. The...
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Oct 1, 2020
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...
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Sep 29, 2020
FDA
The Food and Drug Administration of the US has published the final guidance on the Pilot Accreditation Scheme for Conformity Assessment Program. The document constitutes a final version of the guidance initially issued earlier in September 2019. Due to its legal...
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May 22, 2020
FDA
The Food and Drug Administration (FDA) issues Emergency Use Authorizations (EUAs) in order to expand the availability of vitally important medical devices during the outbreak of the Coronavirus Disease 2019 (COVID-19). The outbreak of the aforementioned disease,...
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Sep 25, 2019
North America
The FDA, the regulating authority in the sphere of medical device circulation of the United States, issued guidance providing additional information on new pilot conformity assessment procedures. ASCA: key points The Accreditation Scheme for Conformity Assessment...
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