CHEMICAL CHARACTERIZATION OF MEDICAL DEVICE (EN ISO 10993-18) Chemical characterization is a crucial step in evaluating the biocompatibility of a medical device. It is done to identify and characterize the chemical constituents (extractables and leachable) which could disclose biological risk to patients and medical practitioners. Extractables are substances that can be released from…
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MDR LABELLING REQUIREMENTS [A] NON-ACTIVE MEDICAL DEVICES Information on the Label Name or trade name of the device. Necessary details for a user to identify the device, the contents of the packaging and the intended purpose of the device. The name, registered trade name or registered trademark and the address of its…
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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 ] Class II medical devices require a 510k submission (premarket notification), while Class III medical devices require a PMA (premarket approval), but what is the difference in the process between the two? A PMA is a more detailed document than a 510k. PMA is used 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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What is Bio-compatibility? What is Bio-compatibility? “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 with…
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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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Clinical Evaluation of Standalone Software: Standalone software with a medical purpose is considered an active medical device, according to the EU MDD/MDR and the UK MDR. The danger to the patient and the users determines the classification. You’ll need to examine the appropriate categorization criteria in order to thoroughly categorise your programme. The importance…
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