Funybubble/fda · Datasets at Hugging Face

Question stringlengths 13 1.05k ⌀	Answer stringlengths 2 801 ⌀
What is the use of electronic copies of medical textbooks or literature articles?	Physician’s Desk Reference
What are not devices because they are not devices?	Software functions
What is the purpose of software quiz apps?	performing any clinical assessment
What is the most relevant comparator in CADe performance assessment?	A study control arm that uses conventional clinical interpretation
What is the purpose of games?	simulate various cardiac arrest scenarios
What is the purpose of these functions?	supports patient-centered health care
What does a software function do?	o Help guide patients to ask appropriate questions to their physician relevant to their particular disease, condition, or concern
What do patients need to do to help match them with appropriate clinical trials?	o Provide tutorials or training videos
What does software functions that automate general office operations in a health care setting not intended for use in the diagnosis of disease or other conditions do?	o Determine billing codes
What does software not provide for hospital emergency rooms?	null
What does software not provide for general-purpose products?	generic aids
What is a note taking function not intended for the mobile platform?	recording audio
What is a software function that is intended for individuals to log, record, track, evaluate, or make decisions related to developing or maintaining general fitn?	Software functions
What do dietary logs, calorie counters, or make dietary suggestions provide?	dietary suggestions
What is the 21 CFR 886.5540?	Low-vision magnifiers
What should be appropriate for establishing substantial equivalence?	ntrols or a direct comparison with the predicate CADe device
What is the name of the game that allows people to track their scores?	mind-challenging games
What are these software functions meant to enable?	general patient health information management and health recordkeeping activities
What does the software function that prompts the health care professional to manually enter symptomatic, behavioral, or environmental information do?	prompt the health care professional to manually enter symptomatic, behavioral, or environmental information
What is a software function that allows a user to record data?	collect and log
What does a software function provide to a health care professional to consider based on a patient’s cholesterol levels and demographics?	a list of appropriate cholesterol-lowering drugs
What does a software function provide?	easy access to information related to patients’ health conditions or treatments
What does software match patient-specific medical information to?	reference information routinely used in clinical practice
What is the software function that enables the health care professional to independently review the basis for the information?	The software function
What does software function do?	identifies drug-disease interactions and contraindications
What are these software functions?	software functions that provide patients with tools to organize and record health information without providing recommendations to alter or change a previously prescribed treatment or therapy
What is the name of the MRMC analysis software that is used in studies that include distinct cases in each arm?	MRMC analysis software
What is the name of the guidance for information on the criteria relating to this description?	Clinical Decision Support Software
What is a software function specifically marketed to help patients document, show, or communicate to health care professionals regarding potential medical conditions?	Software functions
What is a videoconferencing portal specifically intended for?	medical use
What is the definition of Non-Device-MDDS?	Software functions that are solely intended to transfer, store, convert formats, and display medical device data or results
What are multi-patient displays typically used for?	active patient monitoring to enable immediate awareness for potential clinical intervention
What is considered to be software functions that are solely intended to transfer, store, convert formats, and display medical device data or results, in accordance with the Medical Device Data Systems, Medical Image Sto Answer: Non-Device-MDDS is considered to be software functions that are solely intended to transfer, store, convert formats, and display medical device data or results, in accordance with the Medical Device Data Systems, Medical Image Sto Answer: Non-Device-MDDS is considered to be software functions that are solely intended to transfer, store, convert formats, and display medical device data or results, in accord with the Medical Image Sto Answer: Medical Image Sto Answer: Medical Image Sto Answer: Medical Image Sto Answer: Medical Image Sto Answer: Medical Image Sto Answer: Medical Image Sto Answer: Medical Image Sto Answer: Medical Image Sto Answer: Medical Image Sto Answer: Medical Image Sto Answer: Medical Image Sto Answer: Medical Image Sto Answer: Medical Image Sto Answer: Medical Image Sto Answer: Medical Image?	null
What is the name of the document that contains Nonbinding Recommendations 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, unless such function is Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Nonbinding Recommendations 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, unless such function is Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer:?	null
What is the definition of Non-Device-MDDS and connect to a nursing central station?	Non-Device-MDDS
What isplay (but do not analyze or interpret) medical device data to a physician’s mobile platform for review?	Software functions that are not intended for diagnostic image review
What may these software functions be intended for use in the diagnosis of?	disease or other conditions
What is the OBUMRM software for?	OBUMRM
What is another type of software function that helps patients with diagnosed psychiatric conditions?	software functions that pose lower risk to the public
What is OCD?	obsessive compulsive disorder
What do software functions that prompt a user to enter which herb and drug they would like to take concurrently provide information about?	whether interactions have been seen in the literature
What does software use to provide a list of possible medical conditions and advice on when to consult a health care professional?	a checklist of common signs and symptoms
What are the software functions intended to allow a user to initiate?	a pre-specified nurse call or emergency call using broadband or cellular phone technology
What does software display trends in?	personal health incidents
What does software provide for prediabetes patients?	guidance or tools to help them develop better eating habits or increase physical activity
What does the report based on provide patients and caregivers information about?	drug- drug interactions and relevant safety information (side effects, drug interactions, active ingredient)
What poses a risk to a patient’s safety if the software were to not function as intended?	functionality
What are the software functions that transform a mobile platform into a regulated medical device?	Software functions (typically mobile apps)
What is the term for a conventional reading by the readers without the CADe device?	reader alone
What is a software function that uses a sensor or lead that is connected to a mobile platform to measure and display the electrical signal produced by the heart?	Software functions
What is the software function that uses a sensor or electrode attached to the mobile platform?	electronically amplify and “project sounds associated with the heart, arteries and veins and other internal organs”
What does a sensor attached to the mobile platform do?	null
What does a software function use to record, view, or analyze eye movements for use in the 56 Available at https://www.accessdata.fda.gov/s Answer: 57 Available at https://www.accessdata.fda.gov/s Answer: Answer: 57 Available at https://www.accessdata.fda.gov/s Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer:: Answer:: Answer::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::?	null
What is the software function that uses tools within the mobile platform intended for?	conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders
What does accelerometer measure?	degree of tremor caused by certain diseases
What is the LEL code?	882.505
What is the possible product code for NBW?	21 CFR 862.1345
What is a software function that uses a microphone or speaker within a mobile platform to serve as a audiometer to allow health care professionals to determine hearing loss at different frequencies?	null
What are these nonbinding Recommendations oversight?	These software functions are those that control the operation or function (e.g., changes settings) of an implantable or body worn medical device
What is the product code for KPR?	21 CFR 892.1680
What is the purpose of randomizing readers, cases, and reading scenarios?	reduce bias in performance measures
What is the focus of FDA's regulatory oversight?	Software functions that are used in active patient monitoring or to analyze patient- specific medical device data
What is the possible product code(s): LLZ (21 CFR 892.2050)?	null
What is the possible product code(s): LLZ (21 CFR 892.2050)?	null
What is the software function that provides recommendations for FDA-approved treatments based on the findings of the Next Generation Sequencing 28 Contains Nonbinding Recommendations (NGS) Analyzer?	QIC.58
What does the software function indicate?	whether to transf
What is the name of the CDS Guidance that describes the examples of Device Software Functions?	Section V.C
What is the name of the part of 21 CFR Part 807 that requires manufacturers of medical devices to register their establishments62 with FDA?	Establishment Registration and Medical Device Listing
What is the registration and listing requirement?	a means of keeping FDA advised of who is manufacturing devices, and of the types of devices an establishment is manufacturing
What does IDE allow an investigational device to be used in a clinical study?	an IDE
What is the definition of an Establishment?	“a place of business under one management at one general physical location at which a device is manufactured, assembled, or otherwise processed.”
What is the name of the webpage that provides information regarding the investigational device exemption?	“Device Advice: Investigational Device Exemption.”69
What does the guidance for Industry and Food and Drug Administration Staff represent?	the current thinking of the Food and Drug Administration (FDA or Agency) on this topic
How long does it take to separate each reading session in time?	at least four weeks
What does the QS regulation provide for manufacturers to develop and follow?	a framework
What is the IDE regulations part 812 of?	IDE regulations
What is the name of the document that requestsfeedback?	fda-guidance-documents
What must manufacturers do to ensure safe and effective operation of the device?	appropriately verify and validate their device software functions along with the computing platform
What does MDR stand for?	Medical Device Reporting
What must the MDR report contain?	all the information described in 21 CFR 803.52 that is reasonably known to t
What is the name of the facility that can obtain information about a manufacturer?	user facility
What is an example of a request that a manufacturer may initiate?	Upgrading software to reduce risk from a “bug” or unintended response
What is the purpose of a correction to a device?	to reduce a risk to health posed by the device or to remedy
What is the reporting requirement not extend to?	all modifications to devices
What must the device manufacturer keep a record of?	correction
What is Routine servicing defined in?	21 CFR 806.2(l)
What is a medical device subject to regulatory oversight?	software function
What is the phone number for the Division of Industry and Consumer Education?	301-796- 7100
What is the name of the FDA's online course that describes regulatory requirements?	CDRH Learn
Where is the 513(g) process available?	ERROR: type should be string, got " https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance"
What is the name of the document that contains nonbinding recommendations?	513(g)
What does FDA recommend that manufacturers follow for software that MAY be devices and could be device software functions but for which FDA intends to exercise enforcemen?	Quality System (QS) regulation
What does FDA believe should be in place to help ensure that their products consistently meet applicable requirements and specifications?	an adequate quality management system
What are the elements of the QS regulation part of?	FDA’s QS regulation
What is the scoring process?	scoring process
What isSWEBOK?	Software Engineering Body of Knowledge
What does the QS regulation apply to?	medical device hardw
What is the ISO 9001 Quality management systems – Requirements and ISO 13485 Medical devices – Quality management systems – Requirements for regulatory purposes.?	null
What are some examples of principles within the QS regulation that are relevant to all device manufacturers?	risk assessment and management, design controls, and corrective and preventive actions
What is important to the development and manufacture of safe medical devices?	Good design practices

What is the use of electronic copies of medical textbooks or literature articles?

Physician’s Desk Reference

What are not devices because they are not devices?

Software functions

What is the purpose of software quiz apps?

performing any clinical assessment

What is the most relevant comparator in CADe performance assessment?

A study control arm that uses conventional clinical interpretation

What is the purpose of games?

simulate various cardiac arrest scenarios

What is the purpose of these functions?

supports patient-centered health care

What does a software function do?

o Help guide patients to ask appropriate questions to their physician relevant to their particular disease, condition, or concern

What do patients need to do to help match them with appropriate clinical trials?

o Provide tutorials or training videos

What does software functions that automate general office operations in a health care setting not intended for use in the diagnosis of disease or other conditions do?

o Determine billing codes

What does software not provide for hospital emergency rooms?

null

What does software not provide for general-purpose products?

generic aids

What is a note taking function not intended for the mobile platform?

recording audio

What is a software function that is intended for individuals to log, record, track, evaluate, or make decisions related to developing or maintaining general fitn?

Software functions

What do dietary logs, calorie counters, or make dietary suggestions provide?

dietary suggestions

What is the 21 CFR 886.5540?

Low-vision magnifiers

What should be appropriate for establishing substantial equivalence?

ntrols or a direct comparison with the predicate CADe device

What is the name of the game that allows people to track their scores?

mind-challenging games

What are these software functions meant to enable?

general patient health information management and health recordkeeping activities

What does the software function that prompts the health care professional to manually enter symptomatic, behavioral, or environmental information do?

prompt the health care professional to manually enter symptomatic, behavioral, or environmental information

What is a software function that allows a user to record data?

collect and log

What does a software function provide to a health care professional to consider based on a patient’s cholesterol levels and demographics?

a list of appropriate cholesterol-lowering drugs

What does a software function provide?

easy access to information related to patients’ health conditions or treatments

What does software match patient-specific medical information to?

reference information routinely used in clinical practice

What is the software function that enables the health care professional to independently review the basis for the information?

The software function

What does software function do?

identifies drug-disease interactions and contraindications

What are these software functions?

software functions that provide patients with tools to organize and record health information without providing recommendations to alter or change a previously prescribed treatment or therapy

What is the name of the MRMC analysis software that is used in studies that include distinct cases in each arm?

MRMC analysis software

What is the name of the guidance for information on the criteria relating to this description?

Clinical Decision Support Software

What is a software function specifically marketed to help patients document, show, or communicate to health care professionals regarding potential medical conditions?

Software functions

What is a videoconferencing portal specifically intended for?

medical use

What is the definition of Non-Device-MDDS?

Software functions that are solely intended to transfer, store, convert formats, and display medical device data or results

What are multi-patient displays typically used for?

active patient monitoring to enable immediate awareness for potential clinical intervention

What is considered to be software functions that are solely intended to transfer, store, convert formats, and display medical device data or results, in accordance with the Medical Device Data Systems, Medical Image Sto Answer: Non-Device-MDDS is considered to be software functions that are solely intended to transfer, store, convert formats, and display medical device data or results, in accordance with the Medical Device Data Systems, Medical Image Sto Answer: Non-Device-MDDS is considered to be software functions that are solely intended to transfer, store, convert formats, and display medical device data or results, in accord with the Medical Image Sto Answer: Medical Image Sto Answer: Medical Image Sto Answer: Medical Image Sto Answer: Medical Image Sto Answer: Medical Image Sto Answer: Medical Image Sto Answer: Medical Image Sto Answer: Medical Image Sto Answer: Medical Image Sto Answer: Medical Image Sto Answer: Medical Image Sto Answer: Medical Image Sto Answer: Medical Image Sto Answer: Medical Image Sto Answer: Medical Image?

null

What is the name of the document that contains Nonbinding Recommendations 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, unless such function is Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Nonbinding Recommendations 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, unless such function is Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer:?

null

What is the definition of Non-Device-MDDS and connect to a nursing central station?

Non-Device-MDDS

What isplay (but do not analyze or interpret) medical device data to a physician’s mobile platform for review?

Software functions that are not intended for diagnostic image review

What may these software functions be intended for use in the diagnosis of?

disease or other conditions

What is the OBUMRM software for?

OBUMRM

What is another type of software function that helps patients with diagnosed psychiatric conditions?

software functions that pose lower risk to the public

What is OCD?

obsessive compulsive disorder

What do software functions that prompt a user to enter which herb and drug they would like to take concurrently provide information about?

whether interactions have been seen in the literature

What does software use to provide a list of possible medical conditions and advice on when to consult a health care professional?

a checklist of common signs and symptoms

What are the software functions intended to allow a user to initiate?

a pre-specified nurse call or emergency call using broadband or cellular phone technology

What does software display trends in?

personal health incidents

What does software provide for prediabetes patients?

guidance or tools to help them develop better eating habits or increase physical activity

What does the report based on provide patients and caregivers information about?

drug- drug interactions and relevant safety information (side effects, drug interactions, active ingredient)

What poses a risk to a patient’s safety if the software were to not function as intended?

functionality

What are the software functions that transform a mobile platform into a regulated medical device?

Software functions (typically mobile apps)

What is the term for a conventional reading by the readers without the CADe device?

reader alone

What is a software function that uses a sensor or lead that is connected to a mobile platform to measure and display the electrical signal produced by the heart?

Software functions

What is the software function that uses a sensor or electrode attached to the mobile platform?

electronically amplify and “project sounds associated with the heart, arteries and veins and other internal organs”

What does a sensor attached to the mobile platform do?

null

What does a software function use to record, view, or analyze eye movements for use in the 56 Available at https://www.accessdata.fda.gov/s Answer: 57 Available at https://www.accessdata.fda.gov/s Answer: Answer: 57 Available at https://www.accessdata.fda.gov/s Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer:: Answer:: Answer::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::?

null

What is the software function that uses tools within the mobile platform intended for?

conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders

What does accelerometer measure?

degree of tremor caused by certain diseases

What is the LEL code?

882.505

What is the possible product code for NBW?

21 CFR 862.1345

What is a software function that uses a microphone or speaker within a mobile platform to serve as a audiometer to allow health care professionals to determine hearing loss at different frequencies?

null

What are these nonbinding Recommendations oversight?

These software functions are those that control the operation or function (e.g., changes settings) of an implantable or body worn medical device

What is the product code for KPR?

21 CFR 892.1680

What is the purpose of randomizing readers, cases, and reading scenarios?

reduce bias in performance measures

What is the focus of FDA's regulatory oversight?

Software functions that are used in active patient monitoring or to analyze patient- specific medical device data

What is the possible product code(s): LLZ (21 CFR 892.2050)?

null

What is the possible product code(s): LLZ (21 CFR 892.2050)?

null

What is the software function that provides recommendations for FDA-approved treatments based on the findings of the Next Generation Sequencing 28 Contains Nonbinding Recommendations (NGS) Analyzer?

QIC.58

What does the software function indicate?

whether to transf

What is the name of the CDS Guidance that describes the examples of Device Software Functions?

Section V.C

What is the name of the part of 21 CFR Part 807 that requires manufacturers of medical devices to register their establishments62 with FDA?

Establishment Registration and Medical Device Listing

What is the registration and listing requirement?

a means of keeping FDA advised of who is manufacturing devices, and of the types of devices an establishment is manufacturing

What does IDE allow an investigational device to be used in a clinical study?

an IDE

What is the definition of an Establishment?

“a place of business under one management at one general physical location at which a device is manufactured, assembled, or otherwise processed.”

What is the name of the webpage that provides information regarding the investigational device exemption?

“Device Advice: Investigational Device Exemption.”69

What does the guidance for Industry and Food and Drug Administration Staff represent?

the current thinking of the Food and Drug Administration (FDA or Agency) on this topic

How long does it take to separate each reading session in time?

at least four weeks

What does the QS regulation provide for manufacturers to develop and follow?

a framework

What is the IDE regulations part 812 of?

IDE regulations

What is the name of the document that requestsfeedback?

fda-guidance-documents

What must manufacturers do to ensure safe and effective operation of the device?

appropriately verify and validate their device software functions along with the computing platform

What does MDR stand for?

Medical Device Reporting

What must the MDR report contain?

all the information described in 21 CFR 803.52 that is reasonably known to t

What is the name of the facility that can obtain information about a manufacturer?

user facility

What is an example of a request that a manufacturer may initiate?

Upgrading software to reduce risk from a “bug” or unintended response

What is the purpose of a correction to a device?

to reduce a risk to health posed by the device or to remedy

What is the reporting requirement not extend to?

all modifications to devices

What must the device manufacturer keep a record of?

correction

What is Routine servicing defined in?

21 CFR 806.2(l)

What is a medical device subject to regulatory oversight?

software function

What is the phone number for the Division of Industry and Consumer Education?

301-796- 7100

What is the name of the FDA's online course that describes regulatory requirements?

CDRH Learn

Where is the 513(g) process available?

ERROR: type should be string, got " https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance"

What is the name of the document that contains nonbinding recommendations?

513(g)

What does FDA recommend that manufacturers follow for software that MAY be devices and could be device software functions but for which FDA intends to exercise enforcemen?

Quality System (QS) regulation

What does FDA believe should be in place to help ensure that their products consistently meet applicable requirements and specifications?

an adequate quality management system

What are the elements of the QS regulation part of?

FDA’s QS regulation

What is the scoring process?

scoring process

What isSWEBOK?

Software Engineering Body of Knowledge

What does the QS regulation apply to?

medical device hardw

What is the ISO 9001 Quality management systems – Requirements and ISO 13485 Medical devices – Quality management systems – Requirements for regulatory purposes.?

null

What are some examples of principles within the QS regulation that are relevant to all device manufacturers?

risk assessment and management, design controls, and corrective and preventive actions

What is important to the development and manufacture of safe medical devices?

Good design practices