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What is written by entities other than the original medical device manufacturer? | Custom software |
What is not considered MDDS when modifying software for MDDS functionality? | the original software is not |
What is the compliance policy of FDA for Medical image storage devices? | 21 CFR 892.2010 |
What is the purpose of the Policy section? | to remove reference to software functions that are not device functions |
What is the purpose of the guidance document? | for comment purposes only |
What is the purpose of hardware that is intended to transfer, store, convert formats, and display medical device data and results remain devices? | devices |
What is the name of the app that displays medical images directly from a Picture Archiving and Communication System (PACS) server? | software function |
What is the Appendix B of the MMA Guidance intended to be used for? | Examples of mobile apps for which FDA intends to exercise enforcement discretion |
What is a function that displays, displays, or displays medical device data without modifying the d? | Software functions that transfer, store, convert formats, and display medical device data |
What do software functions that meet the definition of MDDS connect to? | a nursing central station |
What has been replaced with “software functions” to clarify that the software functions are Non-Device-MDDS? | mobile apps |
What does the Mobile apps connect to? | bedside (or cardiac) monitors |
What does DRT, MWI, MSX stand for? | 21 CFR 870.2300 |
What is a Mobile apps that are intended to display images for diagnostic review regulated as? | picture archiving and communications system |
What is the definition of Medical Device Data Systems? | null |
What is the definition of Medical Device Data Systems? | Software functions that are intended to Answer: These are software functions that are intended to Answer: Answer: These are software functions that are intended to Answer: Answer: These are software functions that are intended to Answer: Answer: These are software functions that meet the definition of Medical Device Data Systems |
What is the final rule for Medical Device Classification Regulations? | Medical Device Classification Regulations To Conform to Medical Software Provisions in the 21st Century Cures Act |
What is the name of the docket that publishes in the Federal Register? | docket number |
What does the software functions in this example include? | those software functions for a secondary display to a regulated medical device when these apps are not intended to provide primary diagnosis, to be used to make treatment decisions, or to be used in connection with active patient monitoring. |
What has been withdrawn because some software functions no longer meet the definition of a device? | Guidance for the Submission of Premarket Notifications for Medical Image Management Devices |
What is the name of the document that was written in 2000 that is out of date? | ISO 10993-1 |
What is the name of the document that supersedes the use of International Standard ISO 10993-1? | "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" |
What is the name of the U.S. Department of Health and Human Services Center for Devices and Radiological Health Center for Biologics Evaluation and Research? | Food and Drug Administration |
What is the name of the office that the FDA sends comments to? | Dockets Management Staff |
What is the name of the office that provides the guidance for biologics? | Center for Biologics Evaluation and Research |
What is the scope of the ISO 10993 part? | 2 III. Risk Management for Biocompatibility Evaluations |
What is the name of the Attachment that contains Device Master Files for Biocompatibility Evaluations? | Attachment B: Device Master Files for Biocompatibility Evaluations |
What is the name of the biocompatibility evaluation Flow Chart that is attached to the Summary Biocompatibility Documentation? | Biocompatibility Evaluation Flow Chart |
What is the name of the U.S. Department of Health and Human Services Center for Biologics Evaluation and Research? | CBER |
What are the types of Devices included? | Which Types of Devices are Included |
What is the name of the international standard used for the evaluation of medical devices? | ISO 10993-1 |
What can you use if it satisfies the requirements of applicable statutes and regulations? | an alternative approach |
What is the purpose of this guidance? | to provide further clarification and updated information on the use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk Answer: Evaluation and testing within a risk |
What is the use of risk-based approaches to determine if biocompatibility testing is needed, chemical assessment recommendations, and recommendations? | the use of risk-based approaches |
What should the sponsor specifically state when assessing new devices? | if the device does not have any direct or indirect tissue contact |
What should be done if the change could affect other parts of the device with direct or indirect contact that were not changed? | a biocompatibility evaluation |
What is the current edition of the FDA-recognized consensus standard(s) referenced in this document? | FDA Recognized Consensus Standards Database |
What do FDA guidances describe? | the Agency's current thinking on a topic |
What is the only non-contact device that has no direct or indirect contact with the body? | software |
What is the name of the U.S. Department of Health and Human Services Center for Biologics Evaluation and Research? | CBER |
What is the name of the series of standards that are not bound by the ISO4 10993? | ISO4 10993 |
What is the ISO 10993-1 used for? | to determine the relevant biocompatibility endpoints for an evaluation |
What does ISO stand for? | International Organization for Standardization |
What stands for Organisation for Economic Co-operation and Development? | OECD |
What is Attachment F: Component and Device Documentation Examples? | outlines example documentation language that we recommend using when comparing the composition of a test article to the composition of a finished medical dev |
What does Attachment H describe? | terms and definitions used in this guidance |
What should be followed in some cases? | biocompatibility recommendations in the device-specific standard should be used instead of the recommendations outlined in ISO 10993- 1 |
What is the reason for subcomponent testing of hemodialyzers? | high surface area of the membrane component |
What is the purpose of ISO 10993-12 recommendations? | if non-membrane components are tested separately |
What may be needed if additional or modified testing is needed? | additional or modified testing |
What is the simplest way to identify information gaps in an IND? | Bridging Within an IND from a Drug Developed in a Prefilled Syringe to a Drug Developed in an Autoinjector |
What is the FDA's Guidance for Industry and Food and Drug Administration Staff? | appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices: Guidance for Industry and Food and Drug Administration Staff |
What is the term used in the definition of a combination product? | may |
What will the final determination on whether additional information should be provided depend on? | the specifics of the final device under consideration |
What is the name of the Supplemental Information Sheets published on the FDA website? | Supplemental Information Sheets |
What is the name of the document that should be provided when a declaration of conformity is submitted? | a copy of the supplemental information used to support the declaration |
What is the result of the DA recognized biocompatibility standards? | significant changes to the recommendations in this document |
What is the name of the guidance available at https://www.fda.gov/regulatory-information/search-fda-guidance- documents/requesting-fda-feedback-combination-products 16See FDA’s Database on Recognized Consensus Standards? | null |
What is the name of the FDA's biocompatibility testing program? | ASCA |
What would be acceptable if it is easier for the sponsor to submit a copy of the test report, which is not required by FDA? | this would be acceptable |
What should be the first step in the biological evaluation of a medical device? | assessment of the device, including the material components, the manufacturing processes, the clinical use of the device including the intended anatomical location, and the frequency and duration of exposure |
What is the draft guidance for Biologic-Device Combination Products called? | Bridging of Data |
What could alter the physicochemical characteristics of the device? | aspects of manufacturing and processing |
What should be considered in the appropriate benefit-risk context? | The interpretation of the overall biocompatibility evaluation |
What should the risk assessment evaluate not only the materials used in the device, but also the processing of the materials, the manufacturing methods (including the sterilization process), and any residuals from manufacturing aids used during the process.? | null |
What should also consider which material components of the device have direct or indirect contact with tissue? | potential exposure duration |
What can be demonstrated by bench testing? | the pulse generator is hermetically sealed and will limit exposure of those chemicals to the surrounding tissues |
What can surface properties, forces on surrounding tissue, geometry, and presence of particula contribute to? | an unwanted tissue response |
What might the original processing for an implanted device include placing the device in to facilitate passivation of the implant surface? | an acid bath |
What could result in pyrogenic reactions (fever) following implantation of the device? | implantation |
What is another source of information on potential biocompatibility risks? | reported experience from other manufacturers using the same material in the same or similar anatomical location |
What can information on potential for irritation or sensitization be useful for? | risk assessment |
What is not binding on FDA or the public? | It does not establish any rights |
What is more applicable for a vascular catheter comprised of a certain polymer? | citing experience with the same polymer in a blood-contacting device |
What is useful if it includes information on recommended processing of the material or component and any biological? | A master file |
What should a master file also contain? | a risk assessment provided by the supplier |
What can be particularly helpful to demonstrate that chemical toxicity testing from a previ? | Chemical analysis |
What can demonstrate that the extractables and leachables in a biocompatibility extract have not changed? | a chemical analysis |
What can be used to evaluate potential carcinogens? | Extraction techniques |
What could affect the biological response in certain scenarios? | device geometry |
What may be insufficient due to the potential for chemical interactions between the material and added chemical? | individual toxicity information |
What should be included in your ri? | what is known about the additional material, the base material, and potential chemical interactions between the two |
What can be used to assess some biocompatibility endpoints? | Threshold of Toxicological Concern |
What is the BLA for drug- 21 device and biologic-device single entity? | single entity |
What could literature inform manufacturers about? | nitinol passivation of a peripheral stent |
What should Sponsors be selective in how literature and other publicly available information are used to inform their risk assessment? | how literature and other publicly available information |
What may not be appropriate to extrapolate use in food to device-specific tissue contact? | null |
What should sponsors also evaluate when considering available literature with respect to specific device materials? | whether such information is relevant in light of the manufacturing and processing for the medical device |
What does the 3Rs stand for? | 3Rs |
What is the name of the study that focuses on the use of TTC and SAR modeling? | Assess and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk |
What should the submission include information on if literature is used in lieu of testing for certain biocompatibility endpoints? | applicability of the dose, route, and frequency of exposure from the literature report(s) as compared to the proposed device use |
What is LOAEL? | Lowest Observed Adverse Effect Level |
What may be used to assess the potential reproductive toxicity of compounds released from devices that are not in direct contact with reproductive tissues? | NOAEL/LOAEL values |
What may not be necessary if the patient’s life expectancy in the intended use population is limited? | testing to address long-term biocompatibility endpoints |
What may result in symptoms that are indistinguishable from the disease state such that the clinical data may not be informative to the biocompatibility evaluation.? | null |
What is the definition of combination products in 21 CFR 3.2? | combination products |
What may not be necessary if there is previous clinical experience with a particular medical device? | biocompatibility testing for complement activation |
What did some clinical studies of specific absorbable medical devices demonstrate? | that the absorption kinetics were not accurately |
What has this information been helpful for evaluating? | a next generation device using an improved bench model for the absorption of the device |
What could affect the final chemistry of an implant made from the same material? | manufacturing and processing |