Chemical Characterization of Medical Devices

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…

Medical Device Labelling

  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…

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…

510K Vs PMA

510 k Vs PMA

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 FDA.…

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…

Biological Safety Testing

What do you mean by Biological Safety Testing?

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…

Clinical Data

Pre-Clinical and Clinical Data

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…

Benefit Risk Analysis

Benefit Risk Analysis

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…