The iso 10993 set entails a series of standards for evaluating the biocompatibility of medical devices to manage biological risk. The fda recognizes the standard iso 10993 for biological evaluation of medical devices, and specific testing requirements for a particular device are found in the guidance document required biocompatibility training and toxicology profiles for evaluation of medical devices, blue book memo, g951. Fda releases new biocompatibility draft guidance brandwood ckc. Identified all the required biocompatibility testings by referencing guidance documents titled blue book memo, g951, use of international standard iso10993, and biological evaluation of medical. K863 was much more commonsensical and pragmatic drawing upon fda s vast repository of institutional knowledge and finding similarities where they can be found. The long awaited refresh of us fda s biocompatibility guidance has finally arrived. Assessment takes place after a number of investigations as defined in usp u. Use of international standard iso 109931, biological. Draft guidance for industry and food and drug administration. Given its biocompatibility and strength, titanium is the ideal material for dental supports and other oral prostheses. Food and drug administration fda held a webinar to clarify their current policy in relation to the use of color additives in medical devices. The biocompatibility of the material is affected by devicespecific features, including the manufacturing processes, tissue contact type and duration of contact. The long awaited refresh of us fdas biocompatibility guidance has finally arrived. Fda blue book memo g951, required biocompatibility training and toxicology profiles for evaluation of medical devices, may 1995.
Well characterized materials widely used in the industry can produce unexpected reactions if processed in a. Federal register effective date of requirement for. It does not create or confer rights for or on any person and does not operate to bind fda or the public. The guidance is firmly rooted in a risk based approach, and provides detailed advice on all aspects of biological safety evaluation. Navigating the new fda draft guidance on iso 10993. Response the biocompatibility testing outlined in the 515b proposed order preamble is consistent with that recommended in the fda guidance document guidance for. Ekg labs leverages its knowledge of extractables, leachables, and iso 10993 biocompatibility to help companies develop combination products and devices for fda approval. Resolving issues prior to submission of a us fda 510k.
How the new fda guidance on biocompatibility affects medical. Standard guide for biocompatibility evaluation of medical. Our experienced professionals are trained in designing and conducting biocompatibility testing as per different industry. Brenda seidman is president of seidman toxicology, a consulting firm located in falls church, va. As is the case with many other us medical device regulations, fda biocompatibility testing guidance may be based on and highly similar to the iso 109931 standard, but not identical. Performance testing bench generally, all submissions should include the information below. Biocompatibility is defined as presence of the mildness of the relation between a physical and its biological environment on the basis of drug delivery 3. Fda finalizes biocompatibility guidance for medical. This is a quantum leap from the old g951 blue book memo. As is the case with many other us medical device regulations, fda biocompatibility testing guidance may be based on and highly similar to the iso 109931. Which devices are required to meet usp class 6 or other. Jun 17, 2016 maybe a quieter life for these little fellows.
Regulatory guidelines for biocompatibility safety testing. Response the biocompatibility testing outlined in the 515b proposed order preamble is consistent with that recommended in the fda guidance document guidance. This document, known as the blue book, was the basis of biocompatibility regulation for decades. Fda finalizes biocompatibility guidance for medical devices. For example, fda defines three different routes of exposure. The contract laboratories are going to have the greatest amount of experience in knowing exactly what the regulators have been expecting. Alperts guidance letter provides general background about fdas previous use of the tripartite guidance and the agencys reasons for adopting the iso 109931. When screening information is needed regarding the biocompatibility of the packaging, cytotoxicity testing from the supplier is typically performed. Our team has years of experience working with a wide variety of combination devices, materials, and pharmaceutical. Evaluation and testing, dated may 1, 1995 starting on september 14, 2016. Note1 tissue includes tissue fluid and subcutaneous spaces note2 for all devices used in extracorporeal circuits.
Per the iso 109931 standard, the downstream cartridge is categorized as an external. The tests that are required depend upon the length and type of contact. The iso 10993 set entails a series of standards for evaluating the biocompatibility of medical. Blue book memo page 1 of7 this guidance was written prior to the february 27, 1997 implementation of fda s good guidance practices, ggps. Combination product biocompatibility iso 10993 analysis. Fda biocompatibility new risk based guidance on iso 10993. Biocompatibility testing is a critical part of the regulatory approval process for medical devices as even the best designed products can produce unintended complications if the materials used cause a biological reaction in the patient. Biocompatibility, tests recommended in 1s0 10993 with the additional tests recommended in blue book memo, g951, for evaluation of devices in contact with mucosal membranes or breached or compromised surfaces for a limited duration, were submitted for pva sponge and results found to. The timing is exquisite the guidance is released as iso tc194 holds its annual meeting in.
Aditi tondulkar regulatory affairs specialist dexcom. This article presents some of the biocompatible materials used in medical practice. Use of international standard iso10993, biological evaluation of medical devices, part 1. These documents were preceded by the tripartite agreement and is a part of the international harmonisation of the safe use evaluation of medical devices. On june 16, 2016, fda issued the final guidance use of international standard iso 109931, biological evaluation of medical devices part 1. The blue book supersedes the tripartite guidance as a guideline for planning biocompatibility testing of medical devices for the u.
Blue book memo page 1 of7 this guidance was written prior to the february 27, 1997 implementation of fdas good guidance practices, ggps. Biocompatibility training and toxicology profiles for evaluation of medical devices, issued on may 1, 1995 g951, with changes limited to cberspecific administrative procedures. The us food and drug administration fda held a telephone conference on 21 st july, 2016, to familiarize industry leaders with the process of biocompatibility testing of medical devices, and how it is using iso 109931 standard for setting device standards. The guidance is firmly rooted in a risk based approach, and provides detailed advice on all aspects. Biocompatibility biocompatibility is the measure of the compatibility of a material with the tissue or physiological system of the patient. The ode guidance memoranda, affectionately referred to as blue book memos, clarify these guidelines and will be added to this list as they become available. K863 was much more commonsensical and pragmatic drawing upon fdas vast repository of institutional knowledge and finding similarities where they can be found. Combination product biocompatibility testing at ekg labs.
Biocompatibility testing eurofins medical device testing. Although i cant claim to be an expert in this area but, i believe that iso 10993 is being used instead of the usp for medical device biocompatibility testing. Dec 01, 2011 fda recommends biocompatibility testing of the device in accordance with fda blue book memo, use of international standard iso 10993, biological evaluation of medical devices part 1. We call ourselves specialists, who are informed and vigilant about the different industries that need biocompatibility testing for developing their medical devices. This guidance is intended to replace the 1995 blue book memo g951. Sep 23, 2016 the us food and drug administration fda held a telephone conference on 21 st july, 2016, to familiarize industry leaders with the process of biocompatibility testing of medical devices, and how it is using iso 109931 standard for setting device standards. Consider these as you design studies for products that are intended for the us market. May 04, 2006 although i cant claim to be an expert in this area but, i believe that iso 10993 is being used instead of the usp for medical device biocompatibility testing.
Mind the gap between iso 10993 and submission to fda. In addition to the tests recommended in the iso standard, the fda has identified additional tests that may be applicable for your medical device. Biocompatibility, tests recommended in 1s0 10993 with the additional tests recommended in blue book memo, g951, for evaluation of devices in contact with mucosal membranes or breached or compromised surfaces for a limited duration, were submitted for pva sponge and results found to be acceptable. Fda releases final guidance regarding biocompatibility. Fda published a draft guidance document on the use of international standard iso 109931 biological evaluation of medical devicespart 1. As a general rule, the blue book memo and iso documents take a broader and more thorough view of biocompatibility than does the u. Use the blue book memo g95 1 use of international standard. Evaluation and testing, blue book memorandum g951, rockville, md, fda, cdrh, office of device evaluation, 1 may 1995. Fda clarifies policy for color additives in medical devices. The sponsor should provide appropriate biocompatibility testing for duration and level of contact. Fda compliance program guidance manual, chapter 48, good laboratory practice nonclinical laboratories program 7348.
A common dictionary definition of biocompatibility is the quality of being compatible with living tissue or a living system by not being toxic or injurious and not causing immunological rejection. Although not stated in a guidance, fda has historically said that biocompatibility can be shown through alternative information not. Evaluation and testing within a risk management process. Fda recommends biocompatibility testing of the device in accordance with fda blue book memo, use of international standard iso 10993, biological evaluation of medical devices part 1. Resolving issues prior to submission of a us fda 510k application. Differences between iso 10993 and submission to fda eurofins. Usp class plastics tests usp class vi pacific biolabs. Under chapter vii, section 721 of the federal food, drug, and cosmetic, color additives are subject to fda approval before they may be used in medical devices that come in. Evaluation and testing within a risk management process in april 20, and this draft marked the first updated direction regarding. Biocompatibility assessment of synthetic sling materials for. Consultants can also be of great value in helping you navigate the regulatory arena.
Final us fda guidance on biocompatibility testing and iso. An alternative approach may be used if such approach satisfies the requirements of the. Fda invites interested persons to submit comments on all three lists, draft language on the proposed a. Pharmacopoeia, and they supersede the usp for evaluating which studies to submit to fda in support of product registrations. Aug 26, 20 14 biocompatibility tests for implants fda blue book memo g951 to support premarket submission, studies conducted according to respective fda recognized standards and are in compliance with 21 cfr part 58 glp regulations are generally required. Although not stated in a guidance, fda has historically said that biocompatibility can be shown through alternative information not just iso 10993 testing. The bone adheres naturally to the superficial titanium dioxide layer, thus avoiding the necessity of any additional coating. All biocompatibility testing and evaluation methods used to mitigate risks should be well documented. Fda has published for comment a new draft guidance on application of iso 10993. The commenter seeks clarity regarding the specific biocompatibility testing fda believes should be conducted and a rationale for any testing not outlined in the blue book memo. Biocompatibility of longterm implanted devices the biocompatibility of a longterm implantable medical device refers to the ability of the device to perform its intended function, with the desired degree of incorporation in the host, without eliciting any undesirable local or systemic effects in that host. The food and drug administration fda or agency is announcing the. This memo was a huge step toward international harmonization of device biocompatibility testing, although there are still some significant differences between fda and european requirements.