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…
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Premarket Notification Vs Premarket Approval 510k Vs PMA 510(k) premarket notification means to prove the substantial equivalence between the subject device and a predicate device. Predicate device is a legally marketed 510(k) cleared device. There are 3 types of 510(k) premarket notification processes to…
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Medical Device Submission Types in US FDA There are mainly 2 types of submission for medical device in FDA based on the classification. The classifications are based on intended use and indications, that is a risk-based classification. In FDA medical device is classified into class I, II and III. Class I devices has lesser…
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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…
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In the NAMSA’s website, it is stated that the biological safety testing or evaluation is conducted by characterizing medical devices based on nature and duration of body contact, assessing the selection of raw materials used for construction, reviewing the manufacturing processes, identifying minimum biological end-points of concern and evaluating any existing research data available for…
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Pre-Clinical and Clinical Data Pre-clinical data are the important testing and safety data collected during research stage before the clinical trials begin. Tests like in-vitro tests, ex-vivo tests, biological evaluation, simulated use, engineering, performance tests, animal tests, computer modelling, lab tests, stability, shelf life etc. come under pre-clinical tests. Clinical data are used to prove…
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Benefit Risk Analysis : When the overall residual risk remains unacceptable and further risk control is not practicable, then there would be a need for risk-benefit analysis. In a risk-benefit analysis, a manufacturer shall review data and literature to determine if the medical benefits of the intended use outweigh the overall residual risk and hence…
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N41 for the clinical evaluation of stand-alone software from the International Medical Device Regulators Forum (IMDRF) provide supporting information to all software developers. This is only guidance document and not a legal binding document.
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…
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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…
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