Skip to main content

Use of International Standard ISO-10993 for Biological Evaluation of

BayBiotech.NET
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'

Comments

Post a Comment

Popular posts from this blog

Amendments for High Risk Device Type Regulatory Pathway

BayBiotech.NET Government Accounting Office (“GAO”) has issued a long-awaited report evaluating the use of the 510(k) process by the Food and Drug Administration (“FDA” or the “Agency”) in the January of 2009. Report mainly focused on Preamendment class III devices. Although most high-risk class III medical devices are subject to the demanding premarket approval (“PMA”) process, preamendment class III devices may be cleared through the 510(k) pathway until FDA issues regulations requiring a PMA. Under the Safe Medical Devices Act of 1990, FDA was required either to reclassify preamendment class III devices into class I or II, or (2) issue regulations requiring PMA approval for the devices, GAO noted that 20 preamendment class III device types have not yet been addressed by the Agency. GAO has urged FDA to take required steps to address the remaining class III devices that continue to be eligible for 510(k) review. As a result of the report, FDA has committed to address al...
Post a Comment
Read more

Harmonization by Doing (HBD): Japan & U.S. Collaboration

BayBiotech.NET HBD is an international cooperative effort by Japan and US for regulatory convergence for Medical Devices. The efforts are focused on to develop global clinical trials and address regulatory barriers for timely device approvals. To address the needs for additional evaluation, the HBD initiative is a pilot project launched jointly by FDA and MHLW-PMDA for the premarket review of device cardiovascular technology. Instead of taking a theoretical approach to harmonization, HBD is focused on Proof of concept by utilizing parallel development, application submissions and review of actual medical device projects. HBD Study intends to collect and analyze regulatory submission data from multiple applications in the U.S. and Japan. The purpose of the study is to further understand differences that may exist with format and content, to define best practices and to improve globally harmonized processes. To read more about the HBD program, follow the link: http://www.fda.gov/M...
Post a Comment
Read more

What to include in Traditional 510(k) Filing for Medical Devices

BayBiotech.NET A 510k is a premarket submission made to FDA to demonstrate that a medical device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device. A Traditional 510(k) submission must include the required elements as per 21 CFR 807.87 (Information required in a premarket notification submission):  the name of device, (the trade or proprietary name), if any, and the common or usual name or classification name of the device.  description of the device, include device specifications and reference applicable guidance documents, special controls, or standards; photographs or engineering drawings should be supplied, if applicable.  comparison with a predicate device(s), indicating similarities and/or differences accompanied by data, as appropriate; this information may include an identification of materials, design considerations, energy expected to be used or delivered by the device, and a description of the operatio...
Post a Comment
Read more