FDA
The Food And Drug Administration (FDA), the US regulating authority in the sphere of medical devices, has published a guidance document describing the process related to requesting a review of the FDA`s decision not to issue certain export certificates for medical...
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...
North America
The medical device regulating authority in the United States, the FDA, issued special warning on cybersecurity threats related to cardiac implantable devices (ICDs). According to the document placed on the official website, the FDA aims to alert both companies and...
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