506J Notification

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 certain devices or an interruption in the manufacture of certain devices. Which leads disruption in supply of that device in the United States. This policy is intended to…

Biological Safety Testing

What is Bio compatibility?

The term Biocompatibility is described for the specific property of a material being compatible with living tissue. Biocompatible materials do not produce a toxic or immunological response when exposed to the body or bodily fluids. The ISO 10993-1:2018 standard defines Biocompatibility as the ability of a medical device or material to perform with an appropriate host…

Clinical Evaluation of Equivalent Devices

Clinical Evaluation of Equivalent Devices What extent of data of medical devices from other manufacturers does needed to demonstrate equivalence? Annex XIV (3) EU MDR, for instance, refers to non-implantable devices of risk classes I – IIb. It specifies, that manufacturers must provide clear evidence that they have sufficient access to the data of the…

Literature Search

Medical Device Literature Search

Literature search is a systematic thorough search of all types of literature ( eg. Books, peer reviewed articles etc). Structured literature reviews essential for clinical evaluation of medical device. Medical device manufacturers need to plan and execute a dedicated strategy for literature monitoring, triage and analysis, and the results of the analysis must translate into…