What is FDA’s Section 506J Notification? Section 506J notification of the FD&C Act requires manufacturers to notify the Secretary of a permanent discontinuance in the manufacture of specific devices or an interruption in the manufacture of certain devices, which leads to disruption in the supply of that device in the United States. This policy is…
What is Biocompatibility? What is Biocompatibility? – “Medical devices that come into direct or indirect contact with the body” are assessed “for the possibility for an unacceptable adverse biological reaction caused by contact of the device’s component materials with the body.” The term Biocompatibility is described for the specific property of material being compatible…
A literature search is a systematic thorough search of all types of literature ( eg. Books, peer-reviewed articles, etc). Structured literature reviews are essential for the clinical evaluation of the medical devices. Medical device manufacturers need to plan and execute a dedicated strategy for literature monitoring, triage, and analysis, and the results of the analysis…