Question
stringlengths 13
1.05k
⌀ | Answer
stringlengths 2
801
⌀ |
|---|---|
What should users have in the device labeling to allow them to manage risks associated with software components? | known vulnerabilities, configuration specifications, and other relevant security and risk management considerations |
What does SBOM stand for? | SBOM |
What does source code backup involve? | storing (and updating as needed) a separate copy of the source code |
What does an SBOM help facilitate? | risk management processes |
What should be maintained as part of the device’s configuration management? | SBOM or an equivalent capability |
What should you demonstrate if you are considering data reuse in the evaluation of your CADe device? | that reusing any part of the test data does not introduce unreasonable bias into estimates of CADe performance and that test data integrity is maintained |
What are also referred to as “baseline attributes”? | minimum elements |
What is the acronym for the National Telecommunications and Information Administration (NTIA) Multistakeholder Process on Software Component Transparency document? | “Framing Software Component Transparency: Establishing a Common Software Bill of Materials (SBOM)” |
What is the name of the process that is used to improve software transparency? | Information Administration’s multi-stakeholder process |
What is the software level of support provided through monitoring and maintenance from the software component manufacturer? | software is actively maintained, no longer maintained, abandoned |
What should a manufacturer provide a justification for if the information cannot be included in the premarket submission? | why the information cannot be included in the premarket submission |
What should device manufacturers provide in premarket submissions for components with known vulnerabilities? | • A safety and security risk assessment of each known vulnerability (including device and system impacts); and • Details of applicable safety and security risk controls to address the vulnerability. |
What may have security implications and may also be considered vulnerabilities? | Some anomalies discovered during development or testing |
What is the CWE? | Common Weakness Enumeration |
What might the impact of the anomaly occur sporadically and be assessed to be acceptable from a software risk perspective? | the impact of the anomaly |
What may continue to be identified throughout the device’s TPLC? | Cybersecurity risks |
What is a “firewall”? | to ensure those outside of the regulatory assessment team (e.g., algorithm developers) are completely insulated from knowledge of the radiology images and radiological data |
What can be used to quickly identify vulnerability impacts once a device is released? | threat modeling |
What is the most common type of device that is not marketed but still in use? | marketed devices |
What is needed based on postmarket vulnerabilities and general postmarket cybersecurity risk management? | a new premarket submission |
What is important to ensure that device design appropriately addresses cybersecurity in compliance with the QS regulation? | device design |
What is the length from vulne? | Duration |
What should be provided over multiple time frames based on volume or in response to process or procedure changes to increase efficiencies of these measures over time? | Averages |
What are risks introduced by device reliance on hospital networks, cloud infrastructure, or “other functions” defined in? | those introduced by device reliance on hospital networks, cloud infrastructure, or “other functions” |
What does A security architecture definition process55 demonstrate? | that the risks considered during the risk management process are adequately controlled |
What must a manufacturer establish and maintain under 21 CFR 820.30(c)? | procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device |
What does 21 CFR 820.30(d) state? | design output procedures shall contain or make reference to acceptance criteria and shall ensure that those design outputs that are essential for the proper functioning of the device are identified. |
What is the purpose of a "firewall"? | to insulate personnel responsible for proposing interim protocol changes from knowledge of interim comparative results |
What does NIST 800-160 vol. 1 rev. 1 state? | Engineering Trustworthy Secure Systems |
What does the process also ascertain? | vulnerability and susceptibility to disruptions, hazards, and threats |
What does the details of the security context and trust-boundaries enable? | the identification of the parts of the medical device system in or through which incidents might occur |
What should manufacturers analyze to understand the full environment and context in which the device is expected to operate? | the entire system |
What do FDA recommend that architecture information take? | the form of “views,” and that these views be provided during premarket submissions to demonstrate safety and effectiveness |
What is FDA's recommendation for security controls? | ways to document the resultant security architecture |
What must a manufacturer establish and maintain under 21 CFR 820.30(c)? | procedures |
What is the acronym for the Building Code for Medical Device Software Security? | IEC 81001-5-1 |
What allows manufacturers to achieve the security objectives outlined in Section IV? | Security controls |
What is the name of the category where security controls should be applied across the system architecture? | Appendix 1 |
What do you do when you contemplate the reuse of any test data? | randomly select the data from a larger database that grows over time |
What should manufacturers submit in their premarket submissions to demonstrate that the security controls for the categories above, and further detailed in the recommendations in Appendix 1 have (1) been implemented, and (2) been tested in order to validate that they were effectively implemented.? | null |
What is the FDA's nonbinding recommendation for cybersecurity risk management throughout the device lifecycle? | 22 Contains Nonbinding Recommendations |
What can these views be used to help identify? | impacted fun |
What can architecture views contribute to the demonstration of safety and effectiveness in premarket submissions? | demonstration of safety and effectiveness |
What is the most effective way to provide threat modeling information to FDA? | These views can therefore be effective way to provide threat modeling information to FDA and will naturally scale the documentation provided with the cybersecurity risk of the device. |
What should security context, domains, boundaries, critical user roles, and external interfaces of the medical device system define? | security context |
What should exist throughout the cybersecurity risk management documentation? | traceability |
What should manufacturers provide if one of the views listed above is not appropriate? | an explanation for why the view is not included in the premarket submission |
What should a global system view describe? | the overall medical device system |
What do you maintain to track each time the data is accessed? | a data access log |
What is the possibility of a multi-patient Harm view? | When devices are capable of connecting (wired or wirelessly) to another medical or non-medical product, to a network, or to the Internet |
What can be hacked to perform a device function? | a non-device function |
What can a multiple-device compromise have severe impacts for multiple patients? | impact to the device itself and/or to healthcare facility operations |
What is the view that should include the information recommended in Appendix 2? | multi-patient harm view |
What should describe the end-to-end process that permits software updates and patches to be provided (i.e., deployed) to the device? | updateability and patchability view |
What should the device design provide for? | the protection of the end-to-end path and take into account any additional cybersecurity risk created or posed by those non-manufacturer-controlled technologies |
What should security use cases cover? | various operational states of elements in the medical device system (e.g., power on, standby, transition states) and assess clinical functionality states of the medical device system |
What should each view include? | detailed information as recommended in Appendix 2 |
What are closely related disciplines? | software development and cybersecurity |
What must a manufacturer establish and maintain procedures for verifying? | device design |
What did you do to ensure that the new CADe algorithm was fixed in advance? | ensuring that you fixed the new CADe algorithm in advance (i.e., before application to the test set); and (3) providing information concerning the extent to which you used the same test set or a subset thereof for testing other CADe algorithms or designs, including results reported to the Agency as well as non-reported results |
What type of testing should be submitted in the premarket submission? | Security testing |
What should Manufacturers provide evidence of in their submission? | their boundary analysis and rationale for their boundary assumptions |
What should manufacturers ensure the adequacy of? | cybersecurity risk control |
What is the name of the tool used for? | Vulnerability chaining |
What may be necessary to use third parties to ensure an appropriate level of independence between the two groups? | vulnerabilities or other issues revealed during testing are ap |
What should manufacturers provide for all testing? | their assessment of any findings including rationales for not implementing or deferring any findings to future releases |
What may be small or unlikely in relation to a medical device system? | impact on medical device system functionality |
What should the plans include the vulnerabilities that future software releases will address? | anticipated timelines for release |
What can ensure that security issues are addressed prior to impacting release timelines? | Security testing early in development |
What is the key to ensuring safe and effective use and integration of devices and systems? | Cybersecurity Transparency |
What is the chance that you evaluate a new CADe algorithm in a subsequent study using the same test data set that you used for a prior CADe algorithm? | substantially reduce the chance |
What is a medical device deemed misbranded if its labeling is false or misleading in any particular? | section 502(a)(1) |
What does FDA believe informing users of security information through labeling may be an important part of? | design and development activities |
What should be detailed and considered for inclusion as tasks during usability testing? | Any risks transferred to the user |
What is the name of the part of the Guidance that FDA issued on applying Human Factors and Usability Engineering to Medical Devices? | Part 4-1: Product security development life-cycle requirements |
What is the exact location in the labeling for specific types of information? | operator’s manual, security implementation guide |
What should be understandable to the intended audience? | Instructions to manage cybersecurity risks |
What is the name of the product specifications that are related to recommended cybersecurity controls? | device instructions and product specifications |
What should users be able to do with ports in their device? | indicate whether the ports are incoming, outgoing, or both, along with approved destination end-points |
What should users do upon detection of a cybersecurity vulnerability or incident? | respond |
What should the SBOM be in? | machine-readable format |
What are the subsets of test sets that you have never been used before? | the portion of the test set that you have never been used before |
What could be security event types? | configuration changes |
What is the name of the feature that disabling ports/communications? | backup mode |
What is the name of the end point protections that Secure configurations may include? | allow lists, deny lists |
What is the name of the security event management software? | Security Information and Event Management |
What is the manufacturer unable to provide at the end of support? | security patches or software updates |
What is the Manufacturer Disclosure Statement for Medical Device Security outlined in? | MDS266 |
What is the 21 CFR 820.100? | vulnerabilities that are identified after releasing the device |
What is available at https://www.nema.org/standards/view/manufacturer-disclosure-statement-for-medical-device-security 67 Available at https://healthsectorcouncil.org/thejoint-security-plan/ 30 Contains Nonbinding Recommendations addressed how to maintain the safety and effectiveness of the device after marketing authorization is achieved.? | null |
What is Patching capability? | rate at which update can be delivered to devices |
What is the name of the nonbinding recommendation appendix? | Security Control Categories and Associated Recommendations |
What does the reference standard indicate for patient data? | whether the disease/condition/abnormality is present |
What is Authentication of information69? | where the device and the system in which it operates are able to prove that information originated at a known and trusted source, and that the information has not been altered in transit between the original source and the point at which authenticity is verified |
What is the purpose of authentication? | to prove the identity of an endpoint (whether hardware and/or software) from which it is sending and/or receiving information, or authorized user/operator at that endpoint |
What should devices prove to prove the authenticity of information that they generate? | the authenticity of information that they generate |
What is the state of currently running software? | state |
What is the definition of information? | software/firmware itself, as well as input and output data |
What is the main reason for weak schemes? | an unauthorized user can easily emulate the correct behavior and appear to be authorized |
What is the purpose of cryptographic keys? | the integrity of the devices that hold or otherwise leverage those keys |