FDA
The Food and Drug Administration (FDA), the US regulating authority, has updated the information materials dedicated to importing and exporting medical devices. Importing and Exporting: the Basics According to the general rule, the entity involved in the...
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...
FDA
The Food and Drug Administration (FDA) has published guidance dedicated to the procedures associated with the recognition and withdrawals of the FDA-recognized voluntary consensus standards medical device manufacturers may refer to in order to demonstrate conformity...
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 The present document constitutes a final version of the draft guidance...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...
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