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ISO 10993 describes a set of standards for evaluating the biocompatibility of a medical device prior to a clinical study. Based on these guidelines, agency’s modified guidelines entitled "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing," describes a FDA-modified matrix that designates the type of testing needed for various medical devices.
Main criteria to consider when selecting the appropriate tests for biological evaluation of a medical device are the chemical characteristics of device materials and the nature, degree, frequency and duration of its exposure to the body. In general, the main type of tests include: acute, sub-chronic and chronic toxicity; irritation to skin, eyes and mucosal surfaces; sensitization; hemocompatibility; genotoxicity; carcinogenicity; and, effects on reproduction including developmental developmental effects.
However, depending on varying characteristics and intended use of devices as well as the nature of contact, these general tests may not be sufficient to demonstrate the safety of some specialized devices. Additional tests for specific target organ toxicity may be necessary for some devices. If a device is made of materials that have been well characterized chemically and physically in the published literature and have a long
history of safe use, for the purposes of demonstrating the substantial equivalence of such devices to other marketed products, it may not be necessary to conduct all the tests suggested in the FDA matrix of this guidance.
The detailed flowchart and matrix can be followed on the following link:
Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing'
ISO 10993 describes a set of standards for evaluating the biocompatibility of a medical device prior to a clinical study. Based on these guidelines, agency’s modified guidelines entitled "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing," describes a FDA-modified matrix that designates the type of testing needed for various medical devices.
Main criteria to consider when selecting the appropriate tests for biological evaluation of a medical device are the chemical characteristics of device materials and the nature, degree, frequency and duration of its exposure to the body. In general, the main type of tests include: acute, sub-chronic and chronic toxicity; irritation to skin, eyes and mucosal surfaces; sensitization; hemocompatibility; genotoxicity; carcinogenicity; and, effects on reproduction including developmental developmental effects.
However, depending on varying characteristics and intended use of devices as well as the nature of contact, these general tests may not be sufficient to demonstrate the safety of some specialized devices. Additional tests for specific target organ toxicity may be necessary for some devices. If a device is made of materials that have been well characterized chemically and physically in the published literature and have a long
history of safe use, for the purposes of demonstrating the substantial equivalence of such devices to other marketed products, it may not be necessary to conduct all the tests suggested in the FDA matrix of this guidance.
The detailed flowchart and matrix can be followed on the following link:
Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing'
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