Funybubble/fda · Datasets at Hugging Face

Question stringlengths 13 1.05k ⌀	Answer stringlengths 2 801 ⌀
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When was the Guidance for Industry and Food and Drug Administration Staff Document issued?	September 28, 2022
What is the Class II classification?	special controls
What produces biased estimates of CADe positive and negative predictive value?	Enriching a CADe study with subjects having the abnormal condition
What did FDA say about the changes to the device definition?	to exclude certain software functions
What was the FDA guidance on Off-The-Shelf Software Use in Medical Devices?	Off-The-Shelf Software Use in Medical Devices
What is the date of FDA's policy and interpretation of section 3060(a) of the Cures Act?	September 27, 2022
What is the name of the FDA guidance document that presents FDA’s approach to section 520(o)(2) of the FD&C Act?	Multiple Function Device Products: Policy and Considerations
What is the draft of the Guidance for Industry and Food and Drug Administration Staff Document issued on?	September 27, 2019
What is the name of the division that handles digital health?	Division of Digital Health
What is the docket number of FDA-2017-D-6294?	docket number
What is the name of the office that provides the guidance?	Office of Communication, Outreach, and Development
What is the purpose of the Software Function?	Administrative Support
What is the Software Function Intended to Serve as Electronic Patient Records?	Electronic Patient Records
What may introduce bias into CADe performance?	Retrospective reading of image sets
What does the guidance not establish any rights for?	any person
What is the FD&C act?	Federal Food, Drug, and Cosmetic Act
What is the level of guidance made to the listed guidance documents?	Level 2 updates
What is the name of the section in which the guidance document has been withdrawn?	Section IV.D
What is the word that is used in Agency guidance?	should
What amended section 201(h) of the FD&C Act to state that the term device does not include the software functions excluded pursuant to section 520(o)?	Section 3060(d) of the Cures Act
What is the purpose of the term device?	administrative support of a health care facility
What is the purpose of electronic patient records?	for maintaining or encouraging a healthy lifestyle and is unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition
What is the name of the nonbinding recommendation?	Nonbinding Recommendations
What is not intended to transfer, storing, converting formats, or displaying clinical laboratory test or other device data and results?	findings by a health care professional with respect to such data and results, general information about such findings, and general background information about such laboratory test or other device
What refers to the reference standard misclassifying some subjects as having or not having the condition?	Imperfect reference standard bias
What section of the FD&C Act describes limited circumstances when software functions described in 5 are not met?	Section 3060
What is often referred to as clinical decision support software?	clinical decision support software
What is the definition of a software function?	not a device
What is the Cures Act's definition of a software function?	section 520(o)(1)(A) – (D)
What did Section 3060 of the Cures Act create?	a function-specific definition
What does not include a software function that is intended for administrative support of a health care facility?	device
What is the section titled that provides additional clarity for software functions?	Section 3.2.2.
What is LIS?	Laboratory Information Systems
What is a software function that analyzes medical device data in order to provide a notification or flag?	that a parameter is out of range
What is the risk to the safety of users and other persons?	low risk
What can produce potential sources of statistical bias?	The study design of a retrospective reader study
What does Section 520(o)(1)(B) of the FD&C Act affect?	two categories of general wellness intended uses differed
What is not a device as long as its claims are unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease?	a software function with a healthy lifestyle claim
What does Section 520(o)(1) of the FD&C Act describe?	software functions, not hardware products
What does FDA intend to apply to hardware products that otherwise meet the definition of a device?	considerations in the General Wel Answer: FDA intends to apply the considerations in the General Wel Answer: FDA intends to apply the considerations in the General Wel Answer: FDA intends to apply the considerations in the General Wel Answer: FDA
What is the purpose of the software function?	Helping to Reduce the Risk or Impact of Certain Chronic Diseases or Conditions
What is not excluded from the definition of device as modified by this new provis?	these products
What is the purpose of the second category of general wellness intended uses?	help reduce the risk of or help living well with certain chronic diseases or conditions
What is the purpose of a mobile application that only monitors and records daily energy expenditure and cardiovascular workout activities?	to “allow awareness of one’s exercise activities to improve or maintain good cardiovascular health.”
What is the purpose of a software function?	null
What is the purpose of a software function?	alert the user, health care provider, or family member of unhealthy dietary activity
What is the name of the Appendix A of the MMA Guidance?	Examples of mobile apps for which FDA intends to exercise enforcement discretion
What is the first read in the sequential reading design?	unaided by CADe
What does the FD&C Act do to the mobile apps?	o Provide tools to promote or encourage healthy eating, exercise, weight loss, or other activities generally related to a healthy lifestyle or wellness
What does fda.gov provide for a baby?	policy-device-software- functions-and-mobile-medical-applications
What does a software function serve as?	Electronic Patient Records
What is not a device if all three criteria outlined in section 520(o)(1)(C)(i) – (iii) are met?	software functions that are intended to transfer, store, convert formats, or display electronic patient records that are the equivalent of a paper medical chart
What is the name of the section that certifies records in the ONC Health IT Certification Program?	3001(c)(5) of the Public Health Service Act
What is not intended for the purpose of the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition?	medical image data
What is the name of the list of health information technology certified under the ONC Health IT Certification program?	Certified Health IT Product List
What is a PHR not intended for?	diagnosis, cure, mitigation, prevention, or treatment of a disease or condition
What does FDA not intend to enforce compliance to at this time for software functions that are not certified under the ONC Health IT Certification Program?	compliance to the requirements of the FD&C Act
What is not required for ONC certification of these PHR software functions?	ONC certification
What is another concern is that a reader may undercall the unaided reading relative to the reading aided by CADe, producing an enhanced CADe effect?	null
What is the FDA's approach to oversight of software?	FDA’s approach to oversight of software functions that meet the definition of a device in a system with software functions that do not meet the definition of device (products with multiple functions) will be addressed in a separate guidance document.
What is the name of the section that describes examples of mobile apps for which FDA intends to exercise enforcement discretion?	Section V.B
What are these software functions that provide individuals with access to?	health record systems or enable them to gain electronic 13 “Nothing in this subsection shall be construed as limiting the authority of the [FDA] to— (A) exercise enforcement discretion as to any device subject to regulation under this Act . . .” (section 520(o)(4) of the FD&C Act) 14 Available at https://www.fda.gov/regulatory-informatio Answer: Answer:: Answer:::::::::::::::::::::::::::::::::::::: (A) exercise enforcement discretion as to any device subject to regulation under this Act . . . . . . . . . . . . . . . . . . . . . . . . . . . .
What is the name of the category that Contains Nonbinding Recommendations access to health information stored within an EHR system?	Nonbinding Recommendations
What is the name of the act that amends the FD&C Act?	Cures Act
What does FDA not intend to enforce compliance with?	requirements of the FD&C Act that apply to these software functions
What does the Mobile apps provide patients with to organize and track their health information?	simple tools
What are apps that provide simple tools for patients with specific conditions or chronic disease?	o Apps
What does the videoconferencing portals enhance?	communications between patients, health care providers, and caregivers
What is a sub-bullet's functions beyond?	transfer, store, convert formats, or display the equivalent of a paper medical chart
How many independent reading sessions are there?	two
What is the phrase “that is [or are] certif?	” that is [or are] certif
What is the name of the software function that allows a health care provider to access their patient’s personal health record?	Mobile apps
What is the name of the document that helps track or manage patient immunizations?	documenting the need...
What does the mobile app that helps asthmatics record inhaler usage do?	collect and log
What does a clinician send a link to a patient to access after the visit?	the clinical conversation
What is the name of the program that certifies electronic health records?	ONC Health IT Certification Program
What is not a medical device because interacting with PHR or EHR systems is an example of transferring, storing, converting formats, or displaying EHR or PHR data?	interacting with PHR or EHR systems
What is MDDS?	a software, electronic, or electrical hardware that is intended to provide one or more of the following uses, whether or not it is intended for imme
What is an example of a wireless MDDS?	physical communications medium
What is a medical image communications device?	a device that provides electronic transfer of medical image data between medical devices
What is read in reading session 2?	the cases are “crossed over” to the other modality
What is MDDS?	medical image storage devices
What is the purpose of software functions?	to transfer, store, convert formats, and display medical device data and results
What does Section 520(o)(1) of the FD&C Act describe?	software functions, not hardware products
What is the hardware function limited to assisting?	electronic transfer, storage, conversion of formats, or display of medical device data
What is not excluded from the device definition by the Cures Act?	Such medical display hardware devices and other specialized medical display hardware integral to a medical device
What does FDA not regulate in a MDDS multiple function product?	MDDS software functions that meet the definition of 520(o)(1)(D) of the FD&C Act
What does FDA want to provide on the regulation of multifunctional devices?	guidance document
What is general-purpose hardware IT infrastructure intended for?	data transfer
What is not regulated as devices?	display of data (computer monitor)
What is a software function intended to generate alarms or alerts or prioritize patient-related information on multi-patient displays?	alarms or alerts
What is the name of the journal that studies the impact of prevalence and case distribution in diagnostic imaging studies?	Journal of Medical Imaging
What is not excluded from the definition of device under subsection (D)?	software functions that analyze medical device data in order to provide a notification or flag
What has been revised to clarify that software functions that are solely intended to transfer, store, convert formats, and display medical device data and results are not devices and thus are not subject to FDA regulatory requirements?	null
What has the definition of MDDS been revised to describe?	hardware that transfers, stores, converts formats, and displays medical device data
What is the term for the electronic storage and retrieval of medical device data?	The electronic storage and retrieval
What is a software that converts digital data generated by a pulse oximeter into a digital format that can be printed?	null
What is a nonbinding Reco Answer: Answer: Nonbinding Reco Answer: Answer: Nonbinding Reco Answer: Answer: Nonbinding Reco Answer: Nonbinding Reco Answer: Nonbinding Reco Answer: Nonbinding Reco Answer: Nonbinding Reco Answer: Nonbinding Reco Answer: Nonbinding Reco Answer: Nonbinding Reco Answer: Nonbinding Reco Answer: Nonbinding Reco Answer: Nonbinding Reco Answer: Nonbinding Reco Answer: Nonbinding Reco Answer: Nonbinding Reco Answer: Nonbinding Reco Answer: Nonbinding Reco Answer: Nonbinding Reco Answer: Nonbinding Reco Answer: Nonbinding Reco Answer: Nonbinding Reco Answer: Nonbinding Reco?	null
What has been removed from this example?	hardware

null

When was the Guidance for Industry and Food and Drug Administration Staff Document issued?

September 28, 2022

What is the Class II classification?

special controls

What produces biased estimates of CADe positive and negative predictive value?

Enriching a CADe study with subjects having the abnormal condition

What did FDA say about the changes to the device definition?

to exclude certain software functions

What was the FDA guidance on Off-The-Shelf Software Use in Medical Devices?

Off-The-Shelf Software Use in Medical Devices

What is the date of FDA's policy and interpretation of section 3060(a) of the Cures Act?

September 27, 2022

What is the name of the FDA guidance document that presents FDA’s approach to section 520(o)(2) of the FD&C Act?

Multiple Function Device Products: Policy and Considerations

What is the draft of the Guidance for Industry and Food and Drug Administration Staff Document issued on?

September 27, 2019

What is the name of the division that handles digital health?

Division of Digital Health

What is the docket number of FDA-2017-D-6294?

docket number

What is the name of the office that provides the guidance?

Office of Communication, Outreach, and Development

What is the purpose of the Software Function?

Administrative Support

What is the Software Function Intended to Serve as Electronic Patient Records?

Electronic Patient Records

What may introduce bias into CADe performance?

Retrospective reading of image sets

What does the guidance not establish any rights for?

any person

What is the FD&C act?

Federal Food, Drug, and Cosmetic Act

What is the level of guidance made to the listed guidance documents?

Level 2 updates

What is the name of the section in which the guidance document has been withdrawn?

Section IV.D

What is the word that is used in Agency guidance?

should

What amended section 201(h) of the FD&C Act to state that the term device does not include the software functions excluded pursuant to section 520(o)?

Section 3060(d) of the Cures Act

What is the purpose of the term device?

administrative support of a health care facility

What is the purpose of electronic patient records?

for maintaining or encouraging a healthy lifestyle and is unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition

What is the name of the nonbinding recommendation?

Nonbinding Recommendations

What is not intended to transfer, storing, converting formats, or displaying clinical laboratory test or other device data and results?

findings by a health care professional with respect to such data and results, general information about such findings, and general background information about such laboratory test or other device

What refers to the reference standard misclassifying some subjects as having or not having the condition?

Imperfect reference standard bias

What section of the FD&C Act describes limited circumstances when software functions described in 5 are not met?

Section 3060

What is often referred to as clinical decision support software?

clinical decision support software

What is the definition of a software function?

not a device

What is the Cures Act's definition of a software function?

section 520(o)(1)(A) – (D)

What did Section 3060 of the Cures Act create?

a function-specific definition

What does not include a software function that is intended for administrative support of a health care facility?

device

What is the section titled that provides additional clarity for software functions?

Section 3.2.2.

What is LIS?

Laboratory Information Systems

What is a software function that analyzes medical device data in order to provide a notification or flag?

that a parameter is out of range

What is the risk to the safety of users and other persons?

low risk

What can produce potential sources of statistical bias?

The study design of a retrospective reader study

What does Section 520(o)(1)(B) of the FD&C Act affect?

two categories of general wellness intended uses differed

What is not a device as long as its claims are unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease?

a software function with a healthy lifestyle claim

What does Section 520(o)(1) of the FD&C Act describe?

software functions, not hardware products

What does FDA intend to apply to hardware products that otherwise meet the definition of a device?

considerations in the General Wel Answer: FDA intends to apply the considerations in the General Wel Answer: FDA intends to apply the considerations in the General Wel Answer: FDA intends to apply the considerations in the General Wel Answer: FDA

What is the purpose of the software function?

Helping to Reduce the Risk or Impact of Certain Chronic Diseases or Conditions

What is not excluded from the definition of device as modified by this new provis?

these products

What is the purpose of the second category of general wellness intended uses?

help reduce the risk of or help living well with certain chronic diseases or conditions

What is the purpose of a mobile application that only monitors and records daily energy expenditure and cardiovascular workout activities?

to “allow awareness of one’s exercise activities to improve or maintain good cardiovascular health.”

What is the purpose of a software function?

null

What is the purpose of a software function?

alert the user, health care provider, or family member of unhealthy dietary activity

What is the name of the Appendix A of the MMA Guidance?

Examples of mobile apps for which FDA intends to exercise enforcement discretion

What is the first read in the sequential reading design?

unaided by CADe

What does the FD&C Act do to the mobile apps?

o Provide tools to promote or encourage healthy eating, exercise, weight loss, or other activities generally related to a healthy lifestyle or wellness

What does fda.gov provide for a baby?

policy-device-software- functions-and-mobile-medical-applications

What does a software function serve as?

Electronic Patient Records

What is not a device if all three criteria outlined in section 520(o)(1)(C)(i) – (iii) are met?

software functions that are intended to transfer, store, convert formats, or display electronic patient records that are the equivalent of a paper medical chart

What is the name of the section that certifies records in the ONC Health IT Certification Program?

3001(c)(5) of the Public Health Service Act

What is not intended for the purpose of the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition?

medical image data

What is the name of the list of health information technology certified under the ONC Health IT Certification program?

Certified Health IT Product List

What is a PHR not intended for?

diagnosis, cure, mitigation, prevention, or treatment of a disease or condition

What does FDA not intend to enforce compliance to at this time for software functions that are not certified under the ONC Health IT Certification Program?

compliance to the requirements of the FD&C Act

What is not required for ONC certification of these PHR software functions?

ONC certification

What is another concern is that a reader may undercall the unaided reading relative to the reading aided by CADe, producing an enhanced CADe effect?

null

What is the FDA's approach to oversight of software?

FDA’s approach to oversight of software functions that meet the definition of a device in a system with software functions that do not meet the definition of device (products with multiple functions) will be addressed in a separate guidance document.

What is the name of the section that describes examples of mobile apps for which FDA intends to exercise enforcement discretion?

Section V.B

What are these software functions that provide individuals with access to?

health record systems or enable them to gain electronic 13 “Nothing in this subsection shall be construed as limiting the authority of the [FDA] to— (A) exercise enforcement discretion as to any device subject to regulation under this Act . . .” (section 520(o)(4) of the FD&C Act) 14 Available at https://www.fda.gov/regulatory-informatio Answer: Answer:: Answer:::::::::::::::::::::::::::::::::::::: (A) exercise enforcement discretion as to any device subject to regulation under this Act . . . . . . . . . . . . . . . . . . . . . . . . . . . .

What is the name of the category that Contains Nonbinding Recommendations access to health information stored within an EHR system?

Nonbinding Recommendations

What is the name of the act that amends the FD&C Act?

Cures Act

What does FDA not intend to enforce compliance with?

requirements of the FD&C Act that apply to these software functions

What does the Mobile apps provide patients with to organize and track their health information?

simple tools

What are apps that provide simple tools for patients with specific conditions or chronic disease?

o Apps

What does the videoconferencing portals enhance?

communications between patients, health care providers, and caregivers

What is a sub-bullet's functions beyond?

transfer, store, convert formats, or display the equivalent of a paper medical chart

How many independent reading sessions are there?

two

What is the phrase “that is [or are] certif?

” that is [or are] certif

What is the name of the software function that allows a health care provider to access their patient’s personal health record?

Mobile apps

What is the name of the document that helps track or manage patient immunizations?

documenting the need...

What does the mobile app that helps asthmatics record inhaler usage do?

collect and log

What does a clinician send a link to a patient to access after the visit?

the clinical conversation

What is the name of the program that certifies electronic health records?

ONC Health IT Certification Program

What is not a medical device because interacting with PHR or EHR systems is an example of transferring, storing, converting formats, or displaying EHR or PHR data?

interacting with PHR or EHR systems

What is MDDS?

a software, electronic, or electrical hardware that is intended to provide one or more of the following uses, whether or not it is intended for imme

What is an example of a wireless MDDS?

physical communications medium

What is a medical image communications device?

a device that provides electronic transfer of medical image data between medical devices

What is read in reading session 2?

the cases are “crossed over” to the other modality

What is MDDS?

medical image storage devices

What is the purpose of software functions?

to transfer, store, convert formats, and display medical device data and results

What does Section 520(o)(1) of the FD&C Act describe?

software functions, not hardware products

What is the hardware function limited to assisting?

electronic transfer, storage, conversion of formats, or display of medical device data

What is not excluded from the device definition by the Cures Act?

Such medical display hardware devices and other specialized medical display hardware integral to a medical device

What does FDA not regulate in a MDDS multiple function product?

MDDS software functions that meet the definition of 520(o)(1)(D) of the FD&C Act

What does FDA want to provide on the regulation of multifunctional devices?

guidance document

What is general-purpose hardware IT infrastructure intended for?

data transfer

What is not regulated as devices?

display of data (computer monitor)

What is a software function intended to generate alarms or alerts or prioritize patient-related information on multi-patient displays?

alarms or alerts

What is the name of the journal that studies the impact of prevalence and case distribution in diagnostic imaging studies?

Journal of Medical Imaging

What is not excluded from the definition of device under subsection (D)?

software functions that analyze medical device data in order to provide a notification or flag

What has been revised to clarify that software functions that are solely intended to transfer, store, convert formats, and display medical device data and results are not devices and thus are not subject to FDA regulatory requirements?

null

What has the definition of MDDS been revised to describe?

hardware that transfers, stores, converts formats, and displays medical device data

What is the term for the electronic storage and retrieval of medical device data?

The electronic storage and retrieval

What is a software that converts digital data generated by a pulse oximeter into a digital format that can be printed?

null

What is a nonbinding Reco Answer: Answer: Nonbinding Reco Answer: Answer: Nonbinding Reco Answer: Answer: Nonbinding Reco Answer: Nonbinding Reco Answer: Nonbinding Reco Answer: Nonbinding Reco Answer: Nonbinding Reco Answer: Nonbinding Reco Answer: Nonbinding Reco Answer: Nonbinding Reco Answer: Nonbinding Reco Answer: Nonbinding Reco Answer: Nonbinding Reco Answer: Nonbinding Reco Answer: Nonbinding Reco Answer: Nonbinding Reco Answer: Nonbinding Reco Answer: Nonbinding Reco Answer: Nonbinding Reco Answer: Nonbinding Reco Answer: Nonbinding Reco Answer: Nonbinding Reco Answer: Nonbinding Reco?

null

What has been removed from this example?

hardware