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...
FDA
The new article addresses specific factors related to empirical analysis (formative evaluation). Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has...
FDA
The new article describes in detail the matters related to the evaluation of substantial equivalence under the 510(k) premarket notification framework. In particular, the article describes the aspects related to predicate devices – similar medical devices...
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