FDA
The article provides an overview of the applicable regulatory requirements concerning the manufacturing facilities. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...
FDA
The article provides an overview of the regulatory requirements for medical devices used to improve glycemic control. The document constitutes a draft guidance the authority has published in order to collect feedback from industry representatives and other parties...
FDA
The new article describes in detail the aspects related to the intended use of medical devices and the ways it should be considered when evaluating substantial equivalence. Table of Contents The Food and Drug Administration (FDA or...
FDA
The new article addresses the matters related to data collection and describes in detail different types of information and the ways it could be collected. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating...
FDA
The new article provides a brief overview of the human factors validation testing and also addresses certain specific aspects associated thereto, including the ones related to the test participants. Table of Contents The Food and Drug...
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