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...
FDA
The first article provides an overview of the guidance document dedicated to the human factors and the way they should be considered when developing user interfaces for medical devices. Table of Contents The Food and Drug Administration (FDA or the...
China
Under the general rule, combination products constitute a specific group of products consisting of both medicine (drug) and medical device. In such a case, both products (medicine drug and medical device) are supplied together and intended to be used together for a...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the principles of software validation. The scope of the document covers, inter alia, the aspects...
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