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What is the purpose of LLNA? | evaluate use of LLNA tests for medical devices on a case-by-case basis for medical devices |
What is the exception to the LLNA testing? | nickel-containing metals |
What does the standard state about nsitization? | a positive control does not need to be included in every assay, but may be run at regular intervals which shall not exceed six months |
What can be used to test device materials in aqueous solutions? | The LLNA |
What is the most important thing to use to achieve adequate exposure? | positive control results |
What does FDA encourage applicants to contact to discuss specific information needed to support their individual applications? | FDA |
What is unknown in an LLNA test? | whether chemicals will be able to penetrate the skin |
What is the LLNA: 2-Bromodeoxyuridine-Enzyme Linked Immunosorbent Assay (BrdU-ELISA) test or the LLNA: Daicel Adenosine Triphosphate (DA) test? | null |
What is the potential for false positive results? | there is a potential for false positive results that could limit the usefulness of this type of LLNA test |
What is the potential for for borderline positive responses between an SI of 1.8 and 2.5? | false positive results |
What is the 1% pluronic L92 surfactant used for? | testing pesticide formulations |
What is the only way to determine if a device has indirect contact with circulating blood? | in vivo thrombogenicity testing |
What is not necessary when hemocompatibility testing is determined to be not necessary? | hemocompatibility testing |
What is the name of the standard practice for assessment of hemolysis? | ASTM F756 Standard Practice for Assessment of Hemo |
What is the only method that we recommend for hemolysis testing of devices having indirect contact with circulating blood? | indirect (extract) method |
What is an issue with high shear stress due to blood flow? | high shear stress |
What does the word should mean in Agency guidances? | something is suggested or recommended, but 81 not required |
What is a complex process and is a function of physical and chemical properties of the device? | Medical device-mediated complement activation |
What is the most likely cause of a device having direct contact with blood? | complement activation |
What should be provided to confirm that the testing is capable of detecting differences between negative and positive reference controls. test validation information? | null |
What is the legal name of the comparator device used for complement activation testing? | comparator device |
What can be used to test complement activation? | in vivo animal models |
What is the safety of cardiovascular stents? | is co Answer: the safety of cardiovascular stents is co |
What is the animal model used for the evaluation of mmonly? | an animal model |
What is the name of the 2010 J Immunol Methods article that describes the preparation of serum for functional complement assays? | 352 (1-2): 195- 197 |
What should be used to minimize vessel trauma at the implant site? | implantation technique |
What is the purpose of explantation technique? | to ensure minimal disruption of adhered thrombus and to minimize post-mortem clot formation |
What are drugs, devices, and biological products constituent parts of? | a combination product |
What is a device that is not subject to in vivo animal studies? | oxygenators |
What is PTT? | Partial Thromboplastin Time |
What masks any activation caused by the device or its component materials? | the activating substances |
What is recommended for tests that require large blood volumes? | mmendations simulated clinical flow conditions |
What is the evaluation might include? | additional in vitro or in vivo testing |
What is an example of a non-anticoagulated animal study that may be needed in certain instances? | acute (e.g., four to six hours) |
What may be necessary to screen for device-related characteristics? | surface defects |
What may also be beneficial in some cases? | a detailed analysis of your device geometry and surface as compared to a legally marketed device |
What is used to help protect pa? | pyrogen limit specifications |
What are chemicals that can leach from a medical device during device use? | material- mediated pyrogens |
What are CADe devices used for? | mammography breast cancer, ultrasound breast lesions, radiograph lung nodules, and radiograph dental caries |
What is FDA committed to applying a 92 consistent, risk-based approach to address? | similar regulatory questions |
What is the USP 151> Pyrogen Test? | USP Rabbit Test |
What is the recommended temperature for t sensitive materials? | 37 °C |
What is the purpose of data regarding the thrombogenic potential of a device? | comparative purposes |
What is traditionally addressed as part of the sterility assessment? | Bacterial pyrogens |
What is an acceptable method for implantation testing if characteristics of the device geometry may confound interpretation of this test? | to use device sub-components or coupons |
What is the name of the part of ISO 10993-6 that describes the Biological evaluation of medical devices? | Part 6: Tests for local effects after implantation |
What can be assessed as part of in vivo animal studies? | overall device safety |
What is FDA’s guidance document called? | Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile |
What is the sterility guidance written to address? | sterility information for 510(k) submissions |
What is the FDA's guidance titled? | General Considerations for Animal Studies Intended to Evaluate Medical Devices |
What is the final rule on Postmarketing Safety Reporting for Combination Products published? | December 20, 2016 |
What is not needed when clinically relevant implantation studies are conducted? | Muscle or subcutaneous implantation tests |
What may result in an exaggerated response not observed in the site-specific implantation study? | any materials eluted over time from the test article may be contained within the capsule |
What should be considered even when clinically relevant implantation studies are performed? | muscle implantation studies |
What may be used to select interim assessment time points? | in vitro degradation testing |
What may be needed to demonstrate the risk of the known genotoxin? | Chemical characterization |
What is requested when the genotoxicity profile has not been adequately established? | Genotoxicity testing |
What is recommended because of the high surface area, the associated increased potential for chemical leaching, and introduction of any leachables into the systemic? | genotoxicity evaluations |
What is the test conducted with engineered strains of Salmonella typhimurium and Escherichia coli? | 56 Bacterial gene mutation assay |
What is the preferred method for detection of genotoxic mechanisms? | null |
What is the OECD 490 Guidelines for the Testing of Chemicals – In Vitro Mammalian Cell Gene Mutation Tests using the Thymidine Kinase Gene? | A choice of one of the following is recommended |
What is the OECD 487 Guidelines for the Testing of Chemicals – In Vitro Mammalian Cell Micronucleus Test? | in vitro micronucleus assay |
What may be leveraged to support approval of 98 the proposed combination product if an appropriate bridge can be established? | an 96 applicant has its own existing information (or rights of reference to information) about another 97 combination product or a proposed constituent part |
What is the test not need to be performed? | the test does not need to be performed |
What is the CA assay? | bone marrow chromosomal aberration |
What should be repeated in the event of an equivocal result in any of the in vitro assays? | the same assay should be repeated |
What should be performed on undiluted extracts only, unless cytotoxicity is shown to interfere with the performance of the test.? | null |
What should be provided to confirm that final manufacturing of the dev? | additional chemical characterization information |
What is the need for genotoxicity evaluation for combination products that include a biologic? | case-by-case basis |
What is a structure activity relationship modeling technique that is needed in the absence of experimentally derived carcinogenicity information? | SAR |
What is the multifactorial nature of carcinogenesis? | carcinogenesis is multifactorial |
What is the name of the document that would be helpful to a carcinogenicity evaluation? | Attachment B |
What is the TTC approach used for? | to determine if quantification without chemical identifica |
What is needed to address 100 additional questions of safety or effectiveness raised by the proposed use or function of a 101 constituent part in the combination product? | 100 additional questions |
What would be present in an individual worst- case patient exposure situation? | how much of each chemical |
What is the ICH M7 Guideline about? | sensitivity needed |
What is the propensity of the site to develop local tu? | device implant site and propensity of the site to develop local tu |
What is warranted when data are not available to provide an adequate assessment? | carcinogenicity testing |
What is a probable risk? | use of transgenic animal models |
What is the potential effects of medical devices, materials and/or their extracts on reproductive function, embryonic development, and prenatal and early postnatal development? | developmental toxicity |
What is the name of the study that involved the use of chemical neoplasia in laboratory rodents? | 61Huff, J., et al. |
What is a potential for chemical leachables to contact reproductive organs? | novel implant materials |
What does FDA recommend that in vivo degradation assessments be conducted in? | an appropriate animal model |
What is the source of the toxicity of a degrading device? | potential chemicals of concern |
What may raise additional safety and efficacy 110 considerations? | a change in route of 109 administration for a complex biological product |
What risks does testing for toxicological risks pose to the patient? | loss of mechanical properties |
What is the evaluation of safety for devices where the patient-contacting portions may contain potentially toxic chemicals? | chemical risk (i.e., the level of toxicological concern) and the type and duration of exposure |
What may not necessarily be limited to those endpoints identified by ISO 10993-1 for a specific type and duration of contact? | toxicity assessment |
What is the name of the document that describes the toxicological risks of novel materials? | ISO 10993-1 |
What may not be possible to mitigate the toxicological risks with traditional biocompatibility testing? | For some devices including chemicals with known toxicities |
What are some endpoints that may be better assessed through chemical characterization and a review of the literature? | genotoxicity, carcinogenicity, and developmental toxicity |
What may be necessary to determine the cause of a toxici? | additional chemical characterization and toxicology information |
What is needed to support the risk assessment for devices using materials where a “long history of safe use” rationale would not be sufficient to understand the effect of formulation additives and manufacturing methods and conditions on the biocompatibility of the medical device in its final finished form? | null |
What can be used to confirm if there are additional types or quantities of impurities in the new material or component that could impact biocompatibility? | comparative chemical characterization |
What is the name of the biologic licensing agreement? | BLA |
What is an important task for applicants? | Developing a framework that identifies where information gaps may exist in a combination 120 product development program |
What is the CAS number for emical Abstract Services? | CAS |
What would be the name of any other devices marketed? | marketed |
What is the name of the device that is used in the US? | device |
What solvents may be sufficient to support the biocompatibility evaluation of the device? | semi-polar (e.g., isopropyl alcohol, ethyl alcohol, alcohol/water) and non-polar (e.g., hexane) solvents |