FDA The new article highlights the aspects related to the requests for performance data in the context of 510(k) submissions. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in...
FDA The new article highlights certain specific aspects to be considered, including design controls and following steps in clinical evaluation. Table of Contents The Food and Drug Administration (FDA or the Agency), the US...
FDA The new article describes in detail the aspects related to technical characteristics and the way they should be treated in the context of substantial equivalence under the 510(k) framework. Table of Contents The Food and Drug...
FDA The new article is dedicated to iterations during early feasibility studies. 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 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...
