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 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 Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published draft guidance providing additional details regarding eSubmissions. The document is intended to assist medical device manufacturers...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a draft guidance describing the electronic submission template to be used for medical device 510(k) submissions. The document is...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published an information notice dedicated to Automated Endoscope Reprocessors (AERs) – medical devices used to reprocess endoscopes of various...
