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What should be included in the in vivo animal study design with an appropriate study endpoint? | in vivo thrombogenicity, and acute, subchronic, and chronic toxicity |
What may show toxic effects in animal studies? | glutaraldehyde-fixed tissue heart valves |
What is the name of the IDE that is used to review devices granted Breakthrough designation? | Early Feasibility Study |
What is the name of the Guidance for Industry and Food and Drug Administration Staff? | Breakthrough Devices Program |
What would trigger the need for additional studies? | These findings would usually trigger the need for additional studies |
What has FDA not found to provide relevant biocompatibility information? | animal data |
What is the ent part definition in 21 CFR 4.2? | 21 CFR 4.2 |
What would not typically include assessment of biological response? | animal studies |
What can be a starting point for FDA's review? | Standards that address bulk material composition |
What is the effect that manufacturing and processing may have on a polymer? | incorporated into the final finished medical device |
What are other materials that have been reviewed by FDA also relevant for consideration as part of a risk assessment? | Experience with medical device materials |
What should Sponsors be specific in when referencing devices previously reviewed by FDA? | their risk assessment |
What should a sponsor clearly summarize in a submission? | their conclusions regarding their risk asse |
What should the sponsor identify to mitigate any remaining risks? | biocompatibility testing or other evaluations |
What might provide additional context for interpretation? | results of in vivo animal studies |
What should be evaluated considering the intended use of the device and as part of the overa? | potential toxicities identified through biocompatibility testing |
What is the ISO/TS 10993-19 Biological evaluation of medical devices Part 19: Physico-chemical, morphological and topographical characterization of materials? | ISO/TS 10993-19 |
What is the name of the section that applies to products submitted for licensure under the PHS Act? | 351(k) |
What does Attachment C provide an example biocompatibility risk assess? | an example biocompatibility risk assess |
What does FDA review risk assessments as part of? | overall biocompatibility evaluation |
What is the most common way to discuss a risk assessment with FDA? | discuss the planned approach |
What is needed when questionable or inconclusive findings have occurred in any previously conducted biocompatibility evaluations, or in the event that novel materials are used? | null |
What is the hemical analysis protocol used for? | to simulate patient exposure to medical device materials over time |
What should sponsors understand about each component of a medical device? | biocompatibility |
What is the purpose of the mention of Novel materials in this document? | to provide transparency regarding FDA’s current thinking and recommendations regarding biocompatibility evaluation of devices made from these materials |
What is needed to determine if a metal stent has a polymer coating that may separate over time? | biocompatibility evaluation |
What is performed to determine the acceptability of any potential adverse biological response resulting from contact of the component materials of the device with the body? | Biological evaluation of medical devices |
What is the purpose of systematic analysis of a new device intended for human use? | ensure that the benefits provided by the device in its final finished form will outweigh any potential risks produced by device materials over the inte |
What does this document provide guidance regarding? | clinical performance assessment studies for CADe devices applied to radiology images and radiology device data and CA Answer: The use of the word should in Agency guidances means that something is suggested or recommended, but not required |
What is the term used to refer to the process of establishing the scientific relevance of information developed in an earlier phase of the development program or 34 another development program to support the combination product for which an applicant is seeking approval? | bridging |
What should be considered when selecting the appropriate endpoints for biological evaluation of a medical device? | in vitro cytotoxicity; acute, subchronic and chronic toxicity; irritation; sensitization |
What is not sufficient to demonstrate the safety of certain devices? | biocompatibility endpoints identified in Attachment A |
What are two biocompatibility endpoints? | neurotoxicity and immunotoxicity |
What is the stiffness required for the device to perform appropriately? | stiffness |
What is a material that could impact the biological response to the device? | hydrophilic or hydrophobic surface |
What is a sponsor of a legally-marketed device able to explain? | why manufacturing is |
What may Sponsors leverage information from existing marketing applications to support a rationale that the biocompatibility of the device has been established? | Sponsors may also leverage information from existing marketing applications |
What does Part 1 of the ISO 10993 standard provide a framework for? | biological evaluation of medical devices |
What did the focus of the document change from? | how to determine which biocompatibility tests to conduct, to an approach that considers existing information prior to determining if biocompatibility testing is needed |
What is the purpose of leveraging information from other marketing applications? | 510(k)s, PMAs, De Novos, HDEs, and initiation of IDEs |
What must an applicant bridge to leverage the information from an earlier phase of the development program? | current application |
What is the part of ISO 10993-1 that is used for the evaluation of medical devices? | Evaluation and testing within a risk management process |
What should chemical formulation for each component material take into account? | likelihood of direct or indirect tissue contact |
What may not be sufficient to establish the biocompatibility of the device? | this information alone may not be sufficient |
What should be considered for their relevance to the overall biocompatibility evaluation of the device? | The material(s) of manufacture, the device in its final finished form, and possible leachable chemicals or degradation products |
What should be done to devices to facilitate the selection of appropriate endpoints for inclusion in the overall biocompatibility evaluation? | categorization |
What does the FDA not recognize? | ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories |
What should also be provided if a study was not conducted in compliance with the GLP Regulations? | a statement in your submission explaining the reasons why the study was not in compliance with the GLP Regulations |
What should be submitted to the reviewing authority when test data are provided? | complete experimental data |
What should be evaluated with respect to possible changes in biocompatibility? | physical configuration (e.g., size, geometry, surface properties) or intended use of the device |
What does the FDA-Modified Matrix outline? | recommendations for biological effects evaluation |
What is assumed that the 44 applicant owns or has a right of reference or use that allows the applicant to use information 45 from another development program? | the applicant |
What is the definition of nonclinical laboratory study at 21 CFR 58.3(d)? | definition of nonclinical laboratory study |
What is the main benefit of a pacemaker? | If the device has multiple types of exposure, you should include information to address each exposure category identified for the device |
What framework does FDA agree with? | ISO 10993-1 |
What may not be relevant for all devices? | All biological effects included in the matrix |
What information may not always be needed for all submissions of medical devices? | Chemical formulation and processing information |
What should the comparator device be demonstrated to be? | “worst case” |
What may be of limited utility if specific biocompatibility endpoints are not included as part of the data collected for these studies? | In vivo animal data and/or clinical data |
What is the category of the device type? | nature of body contact |
What can differences in the final finished form of a medical device affect? | biocompatibility |
What should undergo the same manufacturing and sterilization processes? | representative test article |
What applies to the following: 53 54 • Human prescription combination products that are the subject of an investigational new 55 drug application (IND) under 21 CFR part 312? | null |
What could occur when all of the components are tested within a medical device in its final finished form? | a more robust tissue response |
What may be appropriate to demonstrate that the surfaces are equivalent in geometry and surface properties? | extraction and surface characterization techniques |
What is the FDA's recommendation for test article preparation? | representative of the device in its final finished form |
What is the purpose of using in vitro degradation methods? | biocompatibility assessment |
What may not be acceptable depending on the materials of manufacture and the degradation testing conditions? | accelerated degradation testing |
What should be targeted to demonstrate? | how the device materials degrade over time |
What is the purpose of chemical analytical testing of the extract? | to determine whether the extract is representative of leachables during the polymerization or degradation processes |
What is the scope of ISO 10993-1? | includes biological hazards arising from Device Mechanical Failure |
What is it possible that mechanical failure could alter? | biological response to the device |
What could change with mechanical loading? | surface topography |
What is the scope of the 505(b)(2) guidance? | discussion of those considerations |
What could result in nickel? | non-optimized passivation layers that can be further compromised by mechanical loading, such as during device placement |
What can be unique properties associated with submicron or nanotechnology components? | submicron ( 1 micron) or nanotechnology compon |
What is the purpose of ISO 10993-12 test conditions? | analysis of submicron component biocompatibility assessments |
What should you select to avoid testing artifacts? | extract conditions (e.g., solvent type) |
What is the context of contemporary literature regarding the validity of individual tests for assessment of devices with submicron components? | standard biocompatibility tests |
What is the assurance that the submicron components will not interfere with the conduct of a chosen test? | Assurance that the submicron components will not interfere |
What is the appropriate amount of test article? | ISO 10993-12 |
What should be provided if there is a need for an alternate extraction ratio? | appropriate justification |
What should be noted in the test report if the recommended surface area to extract volume cannot be achieved? | fluid contacting surface area and extraction volume |
What is the appropriate mixed polarity solvent for extracting both hydrophilic and lipophilic chemicals? | cell culture medium with 5-10% serum |
What is the most recent version of a guidance? | FDA guidance web page |
What is a test that requires intravascularly a polar extract? | material-mediated pyrogenicity |
What are traditional biocompatibility extraction methods? | ISO 10993-12:2021 |
What may devices that contain heat labile or heat sensitive materials have the potential to undergo deformation or material configuration/structural change at high temperature? | drugs, biomolecules, tissue-derived components |
What is the recommended temperature for xtraction? | 37 °C |
What is the maximum duration of contact a device can have with it? | 30 day |
What is the purpose of testing new materials separately? | to further understand the potential toxicity of this component |
What should you consider when conducting any of the tests identified below? | the following issues |
What percentage of serum is used in MEM? | 5-10% |
What is the purpose of a non-standard direct contact study? | where the cells are grown on a material surface |
What terms are used interchangeably and also refer to biological products and biological product constituent parts? | drug and drug constituent part |
What is the level at which cytotoxicity no longer occurs? | level |
What is the Local Lymph 25 Contains Nonbinding Recommendations Node Assay? | sensitization tests |
What is the ISO 10993-10? | Buehler method |
How many animals do we recommend that positive control testing include? | a minimum of five animals |
What is the reason for repeating positive control testing to justify a failed positive control test? | there is no assurance that the test system is working appropriately |