Safety assessment and global regulatory requirements for genetic toxicity evaluations of medical devices

2017 ◽  
Vol 58 (5) ◽  
pp. 375-379 ◽  
Author(s):  
Robert T. Przygoda
Keyword(s):  
Medical Devices ◽  
Safety Assessment ◽  
Regulatory Requirements ◽  
Genetic Toxicity

An Integrated Safety Assessment System for Near-Surface Disposal of Low- and Intermediate-Level Radioactive Waste in Korea

2003 ◽  
Author(s):  
JooWan Park ◽  
Chang-Lak Kim ◽  
Jin Beak Park ◽  
Eun Yong Lee ◽  
Youn Myoung Lee ◽  
...  
Keyword(s):  
Radioactive Waste ◽  
Safety Assessment ◽  
Assessment System ◽  
Intermediate Level ◽  
Radioactive Waste Disposal ◽  
System Level ◽  
Assessment Methodology ◽  
Regulatory Requirements ◽  
Near Surface ◽  
Intermediate Level Radioactive Waste

An integrated safety assessment system to be used for evaluation of near-surface disposal concept has been developed within the framework of safety assessment methodology taken for low- and intermediate-level radioactive waste disposal in Korea. It is to provide an evaluation of the safety of the disposal system in a clear, comprehensive and well-documented manner, and to integrate the results into a defensible package showing reasonable assurance of compliance with regulatory requirements for licensing application. This system is made up of two key components, a system-level safety assessment code and an input database/quality assurance module for safety assessment, which both are interfaced with each other.

scholarly journals Genetic Stability, Inheritance Patterns and Expression Stability in Biotech Crops

2020 ◽  
Vol 4 (4) ◽  
Author(s):  
Laura Privalle ◽  
◽  
Patricia Back ◽  
Apurva Bhargava ◽  
Zach Bishop ◽  
...  
Keyword(s):  
Safety Assessment ◽  
Mrna Level ◽  
Mendelian Inheritance ◽  
Plant Genome ◽  
Regulatory Requirements ◽  
Crop Species ◽  
Inheritance Patterns ◽  
Endogenous Genes ◽  
The Stability ◽  
Biotech Products

Demonstration of the stability of traits newly introduced into a plant genome via genetic engineering approaches comprise a significant portion of the safety assessment that these products undergo prior to receiving the requisite regulatory approvals enabling commercial authorization. Different regions of the world have different regulatory requirements and many ask similar questions from multiple and overlapping perspectives. The entire central dogma, that is stability at the DNA level, mRNA level and protein level, is assessed for each product, although only a few regulatory authorities request data at the mRNA level. In this article, we present inheritance data obtained during the safety assessment of biotech products representing specific transgenic events in several crop species including Brassica napus (canola); canola quality Brassica juncea (yellow seeded canola); Glycine max (soybean), and Gossypium hirsutum (cotton) in which different traits have been introduced. The data presented confirm that all events examined were nuclear insertions that resulted in typical Mendelian Inheritance patterns and that the proteins are expressed similarly across multiple generations regardless of whether they were from backcrossed or outcrossed generations. These results demonstrate that newly inserted genes are transmitted to their progeny in a stable manner similar to that of endogenous genes. Further, the findings demonstrate that assessments of multigenerational stability have very limited value to a safety assessment.

An Overview of FDA Regulatory Requirements for Vascular Devices

2020 ◽  
Vol 07 ◽  
Author(s):  
Monika Targhotra ◽  
Rohan Aggarwal ◽  
Meenakshi K. Chauhan
Keyword(s):  
High Risk ◽  
Drug Administration ◽  
Medical Devices ◽  
Food And Drug Administration ◽  
Survey Method ◽  
Potential Hazard ◽  
Clinical Consideration ◽  
Regulatory Requirements ◽  
Administrative Procedures ◽  
Commercial Center

Background: Likewise with latest medications, the Food and Drug Administration (FDA) endorsement proce-dure is expected to give assurance, when it arrives at the commercial center, a clinical device is efficacious and safe in its planned use. Objective: The objective of the particular review is to give an outline of the FDA survey method for vascular clinical devices. This audit centers principally on the FDA survey route for the high-risk based or type-III class clinical devices that obtain the utmost analysis. Methods: The clinical device guideline is achieved by CDRH. Exacting adjustment to wanted standards is required to get promoting approval. 510 (k), PMA, and HDE are the administrative pathways for acquiring promoting approval by the FDA. The decision of the administrative pathway received by organizations relies basically on the multifaceted nature of the structure, a potential hazard to the strength of client, and safety. Results: Clinical devices are fundamentally imperative to vascular care, and doctors who utilize clinical gadgets ought to be increasingly mindful about the administrative procedures supporting their accessibility. The FDA audits high-risk based devices for safety and adequacy. Conclusion: The rationale for this analysis is to talk about current FDA arrangements identified with the endorsement of medical devices alongside the ramifications of these approaches for clinical consideration, especially with regards to vas-cular care.

Safety assessment of residual amounts of disinfectants based on quaternary ammonium compounds on medical devices

2021 ◽  
pp. 36-39
Author(s):  
Andrey Lvovich Karaev ◽  
◽  
Marina Vasilevna Bidevkina ◽  
Margarita Vladimirovna Matrosenko ◽  
◽  
...  
Keyword(s):  
Medical Devices ◽  
Silicone Rubber ◽  
Quaternary Ammonium ◽  
Safety Assessment ◽  
Quaternary Ammonium Compounds ◽  
Image Analyzer ◽  
Toxicity Index ◽  
Test Items ◽  
Ammonium Compounds

Has been made an assessment of the toxicity of residual amounts of disinfectants after using them on products, made from various materials, with DS solutions based on QAC. The working solutions were used in concentrations from 0.3 to 7 % (by DV). The safety of the studied samples was assessed by the toxicity index "It" (in%) on an AT-05 Image Analyzer. Washing out of the residual amounts of DS in concentrations of 0.3–0.7 % (by DW) did not significantly affect the total time of disinfection treatment or pre-sterilization cleaning. At higher concentrations of solutions, there were differences in the time of washing test items and dishes for receiving safe amounts of DS. It is concluded that it is inexpedient to use solutions based on QAC in a concentration of more than 4.5 % (in terms of DV) for disinfection treatment and pre-sterilization cleaning of products made of natural and silicone rubber. Keywords: disinfectants, quaternary ammonium compounds, product washing, AT-05 image analyzer, to­xicity index.

Engineering Assessment Approach for the Leningrad Nuclear Power Plant In-Depth Safety Assessment

2000 ◽  
Author(s):  
Garill Coles ◽  
Sam McKay ◽  
Jon Young ◽  
Yuri Skok
Keyword(s):  
Power Plant ◽  
Nuclear Power Plant ◽  
Nuclear Power ◽  
Safety Assessment ◽  
Safety Analysis ◽  
Regulatory Compliance ◽  
Regulatory Requirements ◽  
Related Function ◽  
Assessment Approach ◽  
Leningrad Nuclear Power Plant

Abstract Engineering assessment that supports the safety basis for a reactor plant operating license is defined as: “An assessment of a system to determine its adequacy to successfully perform its safety-related function(s) when required.” The approach to engineering assessment of systems at the Leningrad Nuclear Power Plant (LNPP), as part of its in-depth safety assessment (ISA), is unique. The content and format of engineering assessments for western Safety Analysis Reports (SARs) have evolved over time and current requirements are somewhat scattered in the governing documents (USNRC, 1978). Many regulatory guides and requirements (western or eastern) have not kept up with changes in safety analysis technology. Performance of the ISA for LNPP affords the opportunity to rethink the approach to engineering assessments, and to incorporate current methods and latest technology in safety analysis. As an example, for many systems, information about system reliability obtained from a modem Probabilistic Safety Assessment is more comprehensive than that from a Single Failure Analysis as prescribed in SAR content and format guides. Overall, the engineering assessment of LNPP systems looks at five major assessment elements: 1) assessment of regulatory compliance, 2) assessment of operability, 3) assessment of vulnerability, 4) assessment of environmental qualifications, and 5) assessment of reliability. By reorganizing the approach to meeting regulatory requirements, and by looking at engineering assessment in various ways, information can be obtained that goes beyond simply demonstrating regulatory compliance to more fully supporting the safety basis for a plant operating license.

scholarly journals Safety Assessment of Alumina and Aluminum Hydroxide as Used in Cosmetics

2016 ◽  
Vol 35 (3_suppl) ◽  
pp. 16S-33S ◽  
Author(s):  
Lillian C. Becker ◽  
Ivan Boyer ◽  
Wilma F. Bergfeld ◽  
Donald V. Belsito ◽  
Ronald A. Hill ◽  
...  
Keyword(s):  
Corrosion Inhibitor ◽  
Aluminum Hydroxide ◽  
Drug Administration ◽  
Medical Devices ◽  
Safety Assessment ◽  
Expert Panel ◽  
Safety Data ◽  
Over The Counter ◽  
Buffering Agent ◽  
Animal Safety

This is a safety assessment of alumina and aluminum hydroxide as used in cosmetics. Alumina functions as an abrasive, absorbent, anticaking agent, bulking agent, and opacifying agent. Aluminum hydroxide functions as a buffering agent, corrosion inhibitor, and pH adjuster. The Food and Drug Administration (FDA) evaluated the safe use of alumina in several medical devices and aluminum hydroxide in over-the-counter drugs, which included a review of human and animal safety data. The Cosmetic Ingredient Review (CIR) Expert Panel considered the FDA evaluations as part of the basis for determining the safety of these ingredients as used in cosmetics. Alumina used in cosmetics is essentially the same as that used in medical devices. This safety assessment does not include metallic or elemental aluminum as a cosmetic ingredient. The CIR Expert Panel concluded that alumina and aluminum hydroxide are safe in the present practices of use and concentration described in this safety assessment.

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