FDA Draft Guidance on Evidentiary Expectations for 510(k) Implant Devices: Overview
The article highlights the key points associated with the concept of evidentiary expectations in the context of marketing submissions.
The article highlights the key points associated with the concept of evidentiary expectations in the context of marketing submissions.
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...
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...
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...
The Food and Drug Administration (FDA) has developed a guidance document dedicated to the benefit-risk factors to be considered when determining substantial equivalence in premarket notifications (510(k)) with different technological characteristics. The document is...