Funybubble/fda · Datasets at Hugging Face

Question stringlengths 13 1.05k ⌀	Answer stringlengths 2 801 ⌀
What is applicable to devices with cybersecurity considerations?	This guidance document
What is the name of the application that is used to request Premarket Approval Applications?	PMA supplements
What is the intended use of the product?	The term "function" is a distinct purpose of the product
What does this guidance apply to?	devices for which a premarket submission is not required
What is the study population enriched with?	cases containing small colonic polyps
What is the benefit-risk threshold for IDE submissions?	different
What is a shared responsibility among stakeholders throughout the use environment of the medical device system?	medical device cybersecurity
What has led to potential safety concerns across a broad range of devices?	Vulnerabilities identified in commonly used third-party components, like URGENT/1110 and SweynTooth
What is WannaCry Ransomware?	an ever-evolving form of malware designed to encrypt files on a device
What is the FDA’s Cybersecurity webpage?	ERROR: type should be string, got " https://www.cisa.gov/stopransomware/ransomware-101 10 For more information, see FDA’s Cybersecurity webpage"
What is the need for capable deployment of mitigations throughout the total product lifecycle?	TPLC
What is an SPDF?	a set of processes that reduce the number and severity of vulnerabilities in products throughout
What does QS stand for?	Quality System
What is the concept of risk management as described in 21 CFR 820.30(g)?	would remain
What is the name of the FDA rule that would align the device QS with international consensus standards?	21 CFR Part 820
What should the sample size of the study be?	large enough such that the study has adequate power to detect with statistical significance your proposed performance claims
What is ISO 13485?	Medical devices- Quality management systems- Requirements for regulatory purposes
What is the FDA intends to finalize expeditiously?	proposed rule
What is the name of the final guidance on Premarket Software Guidance?	Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
What is the definition of a cyber device?	section 524B(a) of the FD&C Act
What is the purpose of the recommendations in this guidance?	to help manufacturers meet their obligations
What are the principles in this guidance document important to?	the improvement of device cybersecurity
What must manufacturers establish and follow to help ensure that their products consistently meet applicable requirements and specifications?	quality systems
What does section 524B(b)(4) of the FD&C Act require cyber device manufacturers to comply with?	any other such requirements
What is the premarket context of documentation outputs related to the requirements of the QS regulation?	in order to demonstrate a reasonable assurance of safety and effectiveness for certain devices with cybersecurity risks
What is the purpose of this guidance?	to explain how such documentation that may be relevant for QS regulation compliance can also be used to show how a sponsor or manufacturer is addressing cybersecurity considerations relevant to a device.
Powering each cohort for statistical significance should not be necessary unless you are making specific subset performance claims?	null
What does FDA require manufacturers to implement as part of design controls?	development processes that account for and address software risks throughout the design and development process
What is a SPDF?	Secure Product Development Framework
What is the FDA's recommendation for quality audits?	21 CFR 820.22
What is the definition of servicing?	21 CFR 820.200
What is the URL of the website that describes device cybersecurity?	ERROR: type should be string, got " https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-content- premarket-submissions-software-contained-medical-devices"
What is an SPDF?	encompasses all aspects of a product’s lifecycle, including design, development, release, support, and decommission
What is one approach to ensure that the QS regulation is met?	Using an SPDF
What is the key to assessing device cybersecurity?	Authenticity, which includes integrity
What should premarket submissions include information that describes how the above security objectives are addressed by and integrated into the device design?	information
What is the manufacturer not able to account for?	all potential environments of use
What is the patient disease state and indications for the radiologic test?	the patient disease state
What should be addressed in the device design?	these factors
What is a medical device designed from the outset to be secure throughout the device lifecycle?	its system and/or network of use
What could fail to convey potential sources of risks?	A failure to disclose all of the communication interfaces or third-party software
Labeling that does not include sufficient information to explain how to securely configure or update the device may limit the ability of end users to appropriately manage and protect the medical device system?	null
What could lead to compromises in device safety and effectiveness?	Without it, cybersecurity risks could be undisclosed, inappropriately identified, or inappropriately responded to
What should Manufacturers take into account when designing a cybersecurity design?	the larger system in which the device may be used
What is the thermometer used in?	a safety-critical control loop
What should submitters consider including in premarket submissions to FDA documentation generation from those design controls used during the development of a device with cybersecurity risks?	demonstrate reasonable assurance of safety and effectiveness
What does the effectiveness of cybersecurity controls degrade as new risks, threats, and attack methods emerge?	the effectiveness of cybersecurity controls
What is the 21 CFR 807.100(b)(2)(ii)(B))?	21 CFR 807.100(b)(2)(ii)(B))
What is the name of the document that collects patient data?	collection sites
What is the premarket submi?	The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi
What is the 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications?	null
What is the FDA's answer: FDA’ Answer: FDA’ Answer: FDA’ Answer: FDA’ Answer: FDA’ Answer: FDA’ Answer: FDA’ Answer: FDA’ Answer: FDA’ Answer: FDA’ Answer: FDA’ Answer: FDA’ Answer: FDA’ Answer: FDA’ Answer: FDA’ Answer: FDA’ Answer: 510(k)]?	null
What is the importance of addressing cybersecurity risks associated with device connectivity in device design?	The increasingly interconnected nature of medical devices
What is the primary goal of using an SPDF?	to manufacture and maintain safe and effective devices
What is the NIST Framework for Improving Critical Infrastructure Cybersecurity commonly referred to as?	NIST Cybersecurity Framework
What is the JSP 30?	Medical Device and Health IT Joint Security Plan (JSP) 30 and IEC 81001-5-1
What does FDA believe SPDF processes provide?	important considerations for the development of devices that are safe and effective
What is the NIST Cybersecurity Framework?	Cybersecurity Framework
What does FDA not recommend that manufacturers discontinue?	existing, effective processes
What is the data poolability of premarket approval applications based on?	foreign clinical data
What is critical because, given the evolving nature of cybersecurity threats and risks, no device is, or can be, completely secure. security risk management processes?	null
What is the distinction in the performance of these processes?	the scope of possible harm and the risk assessment factors may be different
What can security risk management result in?	indirect or direct patient harm
What does AAMI TIR57 detail?	how the security and safety risk management processes should interface to ensure all risks are adequately assessed
What is the definition of a process that should address the manufacturer’s design, manufacturing, and distribution processes?	QS regulation
What are the TPLC processes?	design and development, manufacturing, postmarket monitoring, delivering device software and firmware updates, and servicing
What describes the security risk management process?	risk management
What should only occur when all relevant risk information is known, assessed, and appropriately communicated to users?	null
What should only occur when all relevant risk information is known, assessed, and appropriately communicated to users?	Risk transfer
What is the name of the document that FDA recommends manufacturers generate?	AAMI TIR57
What should include the documentation elements for the system threat modeling, cybersecurity risk assessment, Software Bill of Materials (SBOM) and component support information?	security risk management report
What should you justify in accordance with good clinical study design?	why non-U.S. data reflect what is expected for a U.S. population
What is the purpose of risk transfer?	to include actions taken to manage risk that shifts some or all of the risk to another user, asset, system, network, or geographic
Where is the DHS Risk Lexicon available?	ERROR: type should be string, got " https://www.cisa.gov/resources-tools/resources/dhs-risk-lexicon"
What is the foundational for optimizing?	Threat modeling
What is the purpose of threat modeling?	to inform and support the risk analysis activities
What should the threat model state about the medical device system?	assumptions
What is the FDA's recommendation for threat modeling documentation?	demonstrate how the medical device system has been analyzed to identify potential security risks that could impact safety and effectiveness
What can be performed and/or reviewed during design reviews?	Threat modeling activities
What does the MDIC/MITRE Playbook for Threat Modeling Medical Devices discuss?	threat modeling process
What should be assessed for residual risks as part of a cybersecurity risk assessment?	security risks and controls
What is the fundamental approach performed in safety risk management under ISO 14971?	non-probabilistic approach
What is a major issue with 510(k) submissions?	foreign data and data poolability
What is the premarket assessment of exploitability of a cybersecurity risk different from?	exploitability assessment of a vulnerability discovered postmarket
What could a premarket exploitability assessment assume?	a worst- case assessment and implement appropriate controls
What should also consider the TPLC of the device?	exploitability of the vulnerability is likely to increase over the device lifecycle
What is the likelihood of a threat actor to exploit a vulnerability to increase over the device lifecycle?	the ability of a threat actor to exploit that vulnerability is likely to increase
What should be provided as part of the premarket submission?	The methods used for scoring the risk pre- and post-mitigation and the associated acceptance criteria
What is the ability of interoperable medical devices to exchange and use information with another medical or nonmedical product, system, or device?	an electronic interface
What may increase the complexity of interfaces to allow for interoperability?	cybersecurity controls
What should not be intended to prohibit a user from accessing their device data?	cybersecurity controls
What should manufacturers document in addition to the recommendations in the Interoperability Guidance?	these considerations
What does medical devices commonly include?	third-party software components
What are CADe devices meant to do?	combine values, measurements, or features extracted from the patient radiological data
What is the Agency investigating if there is no algorithm training between two tests?	the sponsor is investigating the effect of a new prompt type
What is the use of component in this guidance consistent with?	the definition in 21 CFR 820.3
What should device manufacturers document all software components of a device and address or otherwise mitigate risks associated with these software compon?	address or otherwise mitigate risks associated with these software
What is the Design History File required by?	21 CFR 820.30(j)
What is the software supply chain used to demonstrate that manufacturers have adequately ensured cybersecurity risks?	manufacturers have adequately ensured such compliance and documented such history
What is the name of the method used to establish and maintain custodial control of source code throughout the lifecycle of a device?	source code escrow

What is applicable to devices with cybersecurity considerations?

This guidance document

What is the name of the application that is used to request Premarket Approval Applications?

PMA supplements

What is the intended use of the product?

The term "function" is a distinct purpose of the product

What does this guidance apply to?

devices for which a premarket submission is not required

What is the study population enriched with?

cases containing small colonic polyps

What is the benefit-risk threshold for IDE submissions?

different

What is a shared responsibility among stakeholders throughout the use environment of the medical device system?

medical device cybersecurity

What has led to potential safety concerns across a broad range of devices?

Vulnerabilities identified in commonly used third-party components, like URGENT/1110 and SweynTooth

What is WannaCry Ransomware?

an ever-evolving form of malware designed to encrypt files on a device

What is the FDA’s Cybersecurity webpage?

ERROR: type should be string, got " https://www.cisa.gov/stopransomware/ransomware-101 10 For more information, see FDA’s Cybersecurity webpage"

What is the need for capable deployment of mitigations throughout the total product lifecycle?

TPLC

What is an SPDF?

a set of processes that reduce the number and severity of vulnerabilities in products throughout

What does QS stand for?

Quality System

What is the concept of risk management as described in 21 CFR 820.30(g)?

would remain

What is the name of the FDA rule that would align the device QS with international consensus standards?

21 CFR Part 820

What should the sample size of the study be?

large enough such that the study has adequate power to detect with statistical significance your proposed performance claims

What is ISO 13485?

Medical devices- Quality management systems- Requirements for regulatory purposes

What is the FDA intends to finalize expeditiously?

proposed rule

What is the name of the final guidance on Premarket Software Guidance?

Content of Premarket Submissions for Management of Cybersecurity in Medical Devices

What is the definition of a cyber device?

section 524B(a) of the FD&C Act

What is the purpose of the recommendations in this guidance?

to help manufacturers meet their obligations

What are the principles in this guidance document important to?

the improvement of device cybersecurity

What must manufacturers establish and follow to help ensure that their products consistently meet applicable requirements and specifications?

quality systems

What does section 524B(b)(4) of the FD&C Act require cyber device manufacturers to comply with?

any other such requirements

What is the premarket context of documentation outputs related to the requirements of the QS regulation?

in order to demonstrate a reasonable assurance of safety and effectiveness for certain devices with cybersecurity risks

What is the purpose of this guidance?

to explain how such documentation that may be relevant for QS regulation compliance can also be used to show how a sponsor or manufacturer is addressing cybersecurity considerations relevant to a device.

Powering each cohort for statistical significance should not be necessary unless you are making specific subset performance claims?

null

What does FDA require manufacturers to implement as part of design controls?

development processes that account for and address software risks throughout the design and development process

What is a SPDF?

Secure Product Development Framework

What is the FDA's recommendation for quality audits?

21 CFR 820.22

What is the definition of servicing?

21 CFR 820.200

What is the URL of the website that describes device cybersecurity?

ERROR: type should be string, got " https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-content- premarket-submissions-software-contained-medical-devices"

What is an SPDF?

encompasses all aspects of a product’s lifecycle, including design, development, release, support, and decommission

What is one approach to ensure that the QS regulation is met?

Using an SPDF

What is the key to assessing device cybersecurity?

Authenticity, which includes integrity

What should premarket submissions include information that describes how the above security objectives are addressed by and integrated into the device design?

information

What is the manufacturer not able to account for?

all potential environments of use

What is the patient disease state and indications for the radiologic test?

the patient disease state

What should be addressed in the device design?

these factors

What is a medical device designed from the outset to be secure throughout the device lifecycle?

its system and/or network of use

What could fail to convey potential sources of risks?

A failure to disclose all of the communication interfaces or third-party software

Labeling that does not include sufficient information to explain how to securely configure or update the device may limit the ability of end users to appropriately manage and protect the medical device system?

null

What could lead to compromises in device safety and effectiveness?

Without it, cybersecurity risks could be undisclosed, inappropriately identified, or inappropriately responded to

What should Manufacturers take into account when designing a cybersecurity design?

the larger system in which the device may be used

What is the thermometer used in?

a safety-critical control loop

What should submitters consider including in premarket submissions to FDA documentation generation from those design controls used during the development of a device with cybersecurity risks?

demonstrate reasonable assurance of safety and effectiveness

What does the effectiveness of cybersecurity controls degrade as new risks, threats, and attack methods emerge?

the effectiveness of cybersecurity controls

What is the 21 CFR 807.100(b)(2)(ii)(B))?

21 CFR 807.100(b)(2)(ii)(B))

What is the name of the document that collects patient data?

collection sites

What is the premarket submi?

The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi: The premarket submi

What is the 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications?

null

What is the FDA's answer: FDA’ Answer: FDA’ Answer: FDA’ Answer: FDA’ Answer: FDA’ Answer: FDA’ Answer: FDA’ Answer: FDA’ Answer: FDA’ Answer: FDA’ Answer: FDA’ Answer: FDA’ Answer: FDA’ Answer: FDA’ Answer: FDA’ Answer: FDA’ Answer: 510(k)]?

null

What is the importance of addressing cybersecurity risks associated with device connectivity in device design?

The increasingly interconnected nature of medical devices

What is the primary goal of using an SPDF?

to manufacture and maintain safe and effective devices

What is the NIST Framework for Improving Critical Infrastructure Cybersecurity commonly referred to as?

NIST Cybersecurity Framework

What is the JSP 30?

Medical Device and Health IT Joint Security Plan (JSP) 30 and IEC 81001-5-1

What does FDA believe SPDF processes provide?

important considerations for the development of devices that are safe and effective

What is the NIST Cybersecurity Framework?

Cybersecurity Framework

What does FDA not recommend that manufacturers discontinue?

existing, effective processes

What is the data poolability of premarket approval applications based on?

foreign clinical data

What is critical because, given the evolving nature of cybersecurity threats and risks, no device is, or can be, completely secure. security risk management processes?

null

What is the distinction in the performance of these processes?

the scope of possible harm and the risk assessment factors may be different

What can security risk management result in?

indirect or direct patient harm

What does AAMI TIR57 detail?

how the security and safety risk management processes should interface to ensure all risks are adequately assessed

What is the definition of a process that should address the manufacturer’s design, manufacturing, and distribution processes?

QS regulation

What are the TPLC processes?

design and development, manufacturing, postmarket monitoring, delivering device software and firmware updates, and servicing

What describes the security risk management process?

risk management

What should only occur when all relevant risk information is known, assessed, and appropriately communicated to users?

null

What should only occur when all relevant risk information is known, assessed, and appropriately communicated to users?

Risk transfer

What is the name of the document that FDA recommends manufacturers generate?

AAMI TIR57

What should include the documentation elements for the system threat modeling, cybersecurity risk assessment, Software Bill of Materials (SBOM) and component support information?

security risk management report

What should you justify in accordance with good clinical study design?

why non-U.S. data reflect what is expected for a U.S. population

What is the purpose of risk transfer?

to include actions taken to manage risk that shifts some or all of the risk to another user, asset, system, network, or geographic

Where is the DHS Risk Lexicon available?

ERROR: type should be string, got " https://www.cisa.gov/resources-tools/resources/dhs-risk-lexicon"

What is the foundational for optimizing?

Threat modeling

What is the purpose of threat modeling?

to inform and support the risk analysis activities

What should the threat model state about the medical device system?

assumptions

What is the FDA's recommendation for threat modeling documentation?

demonstrate how the medical device system has been analyzed to identify potential security risks that could impact safety and effectiveness

What can be performed and/or reviewed during design reviews?

Threat modeling activities

What does the MDIC/MITRE Playbook for Threat Modeling Medical Devices discuss?

threat modeling process

What should be assessed for residual risks as part of a cybersecurity risk assessment?

security risks and controls

What is the fundamental approach performed in safety risk management under ISO 14971?

non-probabilistic approach

What is a major issue with 510(k) submissions?

foreign data and data poolability

What is the premarket assessment of exploitability of a cybersecurity risk different from?

exploitability assessment of a vulnerability discovered postmarket

What could a premarket exploitability assessment assume?

a worst- case assessment and implement appropriate controls

What should also consider the TPLC of the device?

exploitability of the vulnerability is likely to increase over the device lifecycle

What is the likelihood of a threat actor to exploit a vulnerability to increase over the device lifecycle?

the ability of a threat actor to exploit that vulnerability is likely to increase

What should be provided as part of the premarket submission?

The methods used for scoring the risk pre- and post-mitigation and the associated acceptance criteria

What is the ability of interoperable medical devices to exchange and use information with another medical or nonmedical product, system, or device?

an electronic interface

What may increase the complexity of interfaces to allow for interoperability?

cybersecurity controls

What should not be intended to prohibit a user from accessing their device data?

cybersecurity controls

What should manufacturers document in addition to the recommendations in the Interoperability Guidance?

these considerations

What does medical devices commonly include?

third-party software components

What are CADe devices meant to do?

combine values, measurements, or features extracted from the patient radiological data

What is the Agency investigating if there is no algorithm training between two tests?

the sponsor is investigating the effect of a new prompt type

What is the use of component in this guidance consistent with?

the definition in 21 CFR 820.3

What should device manufacturers document all software components of a device and address or otherwise mitigate risks associated with these software compon?

address or otherwise mitigate risks associated with these software

What is the Design History File required by?

21 CFR 820.30(j)

What is the software supply chain used to demonstrate that manufacturers have adequately ensured cybersecurity risks?

manufacturers have adequately ensured such compliance and documented such history

What is the name of the method used to establish and maintain custodial control of source code throughout the lifecycle of a device?

source code escrow