Nov 9, 2020
FDA
The Food and Drug Administration (FDA), the US regulating authority in the sphere of medical devices, has published final guidance dedicated to the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program, a voluntary pathway simplify the approach to be...
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Oct 13, 2020
FDA
The Food and Drug Administration (FDA) has published a guidance document providing standards specific information on biocompatibility testing of the medical device in the context of the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program. Regulatory...
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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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Feb 7, 2020
North America
The Food and Drug Administration (FDA), the US authority responsible for medical device regulation, published a report describing the steps taken in order to implement the new Accreditation Scheme for Conformity Assessment (ASCA), disclose the current status, and...
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