Funybubble/fda · Datasets at Hugging Face

Question stringlengths 13 1.05k ⌀	Answer stringlengths 2 801 ⌀
What does the guidance not establish any rights for?	any person
What is the FDA's goal in educating manufacturers and distributors about software functions intended for use on mobile platf?	to inform manufacturers, distributors, and other entities
What is a software function that meets the definition of a device deployed on?	a “mobile medical app.”
What can be done simultaneously within a single reader study?	Data collection for ROC, Se, and Sp
What is the FDA website on?	Software as a Medical Device (SaMD)
What does the FD&C act not regulate software functions as?	devices
What does FDA consider the functionality of rather than platform?	software
What was the guidance minorly updated in accordance with?	changes described in the guidance “Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act.”
What is the final rule titled?	Medical Devices; Medical Device Classification Regulations To Conform to Medical Software Provisions in the 21st Century Cures Act
What is the FDA guidance titled?	Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical
What is the name of the law that regulates medical software?	86 FR 20278
What is the name of the FDA's guidance documents?	Nonbinding Recommendations Devices
What are innovators trying to leverage to increase portability?	mobile platforms can offer
What did the use of computer and software products as medical devices grow exponentially after 1989?	use of computer and software products as medical devices
What is the name of the book that Chapman & Hall published in 1991?	Practical Statistics for Medical Research
What does the Agency identify through classification?	specific regulatory requirements that apply to these devices and their manufacturers
What does FDA use the term health care professional to mean?	an individual who is licensed, registered, or certified
What is the name of the allied health professional?	nurse practitioner, registered nurse, licensed practical nurse, clinical social worker
What has FDA previously clarified when a software application is used to analyze medical device data?	when a software application is used to analyze medical device data
What can pose potential risks to public health?	certain software functions that are device functions
What did the Cures Act remove from the definition of device?	certain software functions
What does this guidance clarify and outlines?	FDA’s current thinking
What is the FDA's guidance on Medical Device Accessories?	Medical Device Accessories - Describing Accessories and Classification Pathways
What is the name of the document that describes the changes in the medical software?	changes-existing- medical-software-policies-resulting-section-3060-21st-century-cures-act
What are examples of mobile platforms?	mobile computers
What is the ROC summary performance metric used to assess?	ROC summary performance metric
What is a web-based software application tailored to a mobile platform but executed on a server?	Mobile Medical Application (Mobile Medical App)
What is a mobile app intended to be used as?	an accessory to a regulated medical device; or to transform a mobile platform into a regulated medical device
What is a device intended for use in the diagnosis of?	disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man
What is the purpose of software applications that run on a desktop computer, laptop computer, remotely on a website or “cloud”?	may be subject to device regulation
What determines whether a mobile app meets the definition of a “device”?	intended use
What is an example of a mobile app that makes a light emitting diode operate?	section 201(h)
What is a software function intended for use in performing a medical device function?	diagnosis of disease or other conditions, or the cure, mitigation, treatment
What is regulated under 21 CFR 870.2340?	Electrocardiograph
What is FDA's oversight not determined by?	the platform
What may be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives?	objective intent
What may provide additional information for understanding the expected impact of a device on clinical practice?	Reporting Se and Sp (or Se and recall rate)
What is the name of the person from whom he received the devices?	the person from whom he received the devices
What does the term ‘labeling’ mean?	all labels and other written, printe
What could pose a risk to a patient’s safety if the software applications were to not function as intended?	if the software applications were to not function as intended
What is a “mobile medical app manufacturer”?	any person or entity that manufactures mobile medical apps in accordance with Answer: Answer: Answer: Answer: Answer: a “mobile medical app manufacturer”
What is a mobile medical app manufacturer?	anyone who initiates specifications, designs, labels, or creates a software system or application for a regulated medical device in whole or from multiple software components
What is an example of a mobile medical app manufacturer?	any person or entity that: Creates, designs, develops, labels, re-labels, remanufactures, modifies, or creates a mobile medical app software system from multiple components
What is the second party?	individuals or entities (second party)
What is the process of making a device by chemical, physical, biological, or other procedures?	making by chemical, physical, biological, or other procedures
What is the name of the person who makes final delivery or sale to the ultimate consumer?	the person who makes final delivery or sale to the ultimate consumer
What is the definition of a creator of the original idea for a mobile medical app?	creators
What should you check all methods utilized in your analysis for?	the adequacy of their fit to the data
What would the author be considered?	the manufacturer
What would none of the persons or entities in these examples have to register their establishments, list their products with FDA,25 or submit a premarket application?	Manufacturers or distributors
What is the mobile platform treated as when mobile medical apps are run on a mobile platform?	a component of the mobile medical app’s intended use
What is not regulated by FDA as a medical device?	BrandNamePhone sold to consumers
What does 21 CFR 803.3 define?	definition of manufacturer
What does FDA not consider mobile platform manufacturers to be?	medical device manufacturers
What is the term for providers of general-purpose computer or information technology?	providers
What is a creator of a mobile medical app or a software system that provides users access to the medical device function through a website subscription?	a mobile medical app or a software system
What does a licensed practitioner create that enables attaching an ECG el?	XYZ-recorder
What is not considered a mobile medical app manufacturer if Dr. XYZ is in a telehealth network?	Dr. XYZ is not considered a mobile medical apps manufacturer
What is the name of the document that contains the potential sources of Bias in a Retrospective Reader Study?	Potential Sources of Bias in a Retrospective Reader Study
What should not be necessary unless you intend to make specific performance claims?	Powering any additional units-based analyses for statistical significance
What does the “server software application” provide a service to?	a client software application on a mobile platform
What does 21 CFR 807.65(d) say?	“practitioners licensed by law to prescribe or administer drugs or devices and who manufacture, prepare, propagate, compound, or process drugs or devices solely for use in the course of their professional practice.”
What may be subject to investigational device exemption regulations?	human subjects
What does Appendix A provide examples of?	software functions
What is the Regulatory Approach for Device Software Functions?	V. Regulatory Approach for Device Software Functions
What is the FDA's approach to overseeing device software functions consistent with?	our existing approach
What does FDA believe a subset of device software functions poses the same or similar potential risks to the public health as currently regulated devices if they fail to function as intended?	risks
What must a manufacturer meet to make a device software function?	the requirements associated with the applicable device classification
What is the focus of FDA's regulatory oversight?	software functions
What is an extension of one or more medical devices by connecting37 to such device(s) for purposes of controlli?	Software functions
What is the Recall rate?	the percentage of patients (including diseased and non-diseased patients) that are called back or recalled for additional medical assessment
What is the criterion for not being physically connected to the regulated medical device?	device software functions or mobile medical apps
What is a software function that allows a user to control the delivery of insulin on an insulin pump by transmitting control signals to the pumps from the mobile platform?	mobile apps
What is FDA's guidance document for accessories to medical devices?	“Medical Device Accessories - Describing Accessories and Classification Pathways”39
What are software functions that use attachments, display screens, sensors, or other similar components required to comply with?	the device classification associated with the transformed platform
What is an ECG?	electrocardiograph
What does a software function that displays radiological images for diagnosis transform a mobile platform into?	Medical image management and processing system
What is a cardiac monitoring software classified as under 21 CFR 870.2300?	cardiac monitoring software
What is the 21 CFR 884.2740?	perinatal monitoring system
What is CAD?	image processing software
What is a software function that analyzes readings from a blood glucose monitor and alerts the user of readings outside a predetermined range?	software function
What is the name of the 2008 publication that was published by Radiol?	247(1):12–15
What does FDA encourage manufacturers of device software functions that perform patient- specific analysis to contact?	FDA
What does the CDS Guidance say can help users?	41 21 CFR 892.2050
What does FDA intend to exercise for software functions that pose a low risk to patients?	enforcement discretion
What are some software functions that coach patients with conditions such as cardiovascular disease, hypertension, diabetes, or obesity?	o Software functions that coach patients with conditions such as cardiovascular disease, hypertension, diabetes, or obesity
What is the sole responsibility of the health care professionals who have experience with them in medical applications?	the health care professionals who have experience with them in medical applications
What does an app use to supplement a verbal description in a consultation between health care professionals?	photos of a patient’s skin lesions or wounds
What is the software function intended to provide?	a convenient way for clinicians to perform various simple medical calculations taught in medical
What is the product code NXQ?	medication reminder is a device intended for medical purposes to provide alerts to patients or health care providers for pre-determined medication dosing schedules
What is the APGAR score?	Glasgow Coma Scale score
What is the name of the example of software functions for which FDA intends to exercise enforcement discretion?	Appendix B
What should be clarified and specify a version number if appropriate?	the software implementation
What is the associated regulation for the device software function?	associated controls
What is the name of the regulation that regulates the use of medical devices in the 21 CFR?	Quality System (QS)
What is the name of the nonbinding recommendation for Class III devices?	General Controls
What is the name of the branch that provides technical training to medical device manufacturers?	MATTB
What is the name of the Appendix that provides a representative list of software functions that are NOT Medical Devices?	Appendix A
What does FDA not regulate because these software functions are not considered medical devices?	them
What is not intended to be used as reference material and is not intended for use in the diagnosis of disease or other co Answer: These are not devices because the software is intended to be used as reference material and is not intended for use in the diagnosis of disease or other co Answer: Answer: The FDA does not consider to be devices because the software is intended to be used as reference material and is not intended for use in the diagnosis of disease or other co Answer: 1. Software functions that are intended to provide access to electronic “copies” (e.g., e-books, audio books) of medical textbooks or other reference materials with generic text search capabilities?	null

What does the guidance not establish any rights for?

any person

What is the FDA's goal in educating manufacturers and distributors about software functions intended for use on mobile platf?

to inform manufacturers, distributors, and other entities

What is a software function that meets the definition of a device deployed on?

a “mobile medical app.”

What can be done simultaneously within a single reader study?

Data collection for ROC, Se, and Sp

What is the FDA website on?

Software as a Medical Device (SaMD)

What does the FD&C act not regulate software functions as?

devices

What does FDA consider the functionality of rather than platform?

software

What was the guidance minorly updated in accordance with?

changes described in the guidance “Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act.”

What is the final rule titled?

Medical Devices; Medical Device Classification Regulations To Conform to Medical Software Provisions in the 21st Century Cures Act

What is the FDA guidance titled?

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical

What is the name of the law that regulates medical software?

86 FR 20278

What is the name of the FDA's guidance documents?

Nonbinding Recommendations Devices

What are innovators trying to leverage to increase portability?

mobile platforms can offer

What did the use of computer and software products as medical devices grow exponentially after 1989?

use of computer and software products as medical devices

What is the name of the book that Chapman & Hall published in 1991?

Practical Statistics for Medical Research

What does the Agency identify through classification?

specific regulatory requirements that apply to these devices and their manufacturers

What does FDA use the term health care professional to mean?

an individual who is licensed, registered, or certified

What is the name of the allied health professional?

nurse practitioner, registered nurse, licensed practical nurse, clinical social worker

What has FDA previously clarified when a software application is used to analyze medical device data?

when a software application is used to analyze medical device data

What can pose potential risks to public health?

certain software functions that are device functions

What did the Cures Act remove from the definition of device?

certain software functions

What does this guidance clarify and outlines?

FDA’s current thinking

What is the FDA's guidance on Medical Device Accessories?

Medical Device Accessories - Describing Accessories and Classification Pathways

What is the name of the document that describes the changes in the medical software?

changes-existing- medical-software-policies-resulting-section-3060-21st-century-cures-act

What are examples of mobile platforms?

mobile computers

What is the ROC summary performance metric used to assess?

ROC summary performance metric

What is a web-based software application tailored to a mobile platform but executed on a server?

Mobile Medical Application (Mobile Medical App)

What is a mobile app intended to be used as?

an accessory to a regulated medical device; or to transform a mobile platform into a regulated medical device

What is a device intended for use in the diagnosis of?

disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man

What is the purpose of software applications that run on a desktop computer, laptop computer, remotely on a website or “cloud”?

may be subject to device regulation

What determines whether a mobile app meets the definition of a “device”?

intended use

What is an example of a mobile app that makes a light emitting diode operate?

section 201(h)

What is a software function intended for use in performing a medical device function?

diagnosis of disease or other conditions, or the cure, mitigation, treatment

What is regulated under 21 CFR 870.2340?

Electrocardiograph

What is FDA's oversight not determined by?

the platform

What may be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives?

objective intent

What may provide additional information for understanding the expected impact of a device on clinical practice?

Reporting Se and Sp (or Se and recall rate)

What is the name of the person from whom he received the devices?

the person from whom he received the devices

What does the term ‘labeling’ mean?

all labels and other written, printe

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

if the software applications were to not function as intended

What is a “mobile medical app manufacturer”?

any person or entity that manufactures mobile medical apps in accordance with Answer: Answer: Answer: Answer: Answer: a “mobile medical app manufacturer”

What is a mobile medical app manufacturer?

anyone who initiates specifications, designs, labels, or creates a software system or application for a regulated medical device in whole or from multiple software components

What is an example of a mobile medical app manufacturer?

any person or entity that: Creates, designs, develops, labels, re-labels, remanufactures, modifies, or creates a mobile medical app software system from multiple components

What is the second party?

individuals or entities (second party)

What is the process of making a device by chemical, physical, biological, or other procedures?

making by chemical, physical, biological, or other procedures

What is the name of the person who makes final delivery or sale to the ultimate consumer?

the person who makes final delivery or sale to the ultimate consumer

What is the definition of a creator of the original idea for a mobile medical app?

creators

What should you check all methods utilized in your analysis for?

the adequacy of their fit to the data

What would the author be considered?

the manufacturer

What would none of the persons or entities in these examples have to register their establishments, list their products with FDA,25 or submit a premarket application?

Manufacturers or distributors

What is the mobile platform treated as when mobile medical apps are run on a mobile platform?

a component of the mobile medical app’s intended use

What is not regulated by FDA as a medical device?

BrandNamePhone sold to consumers

What does 21 CFR 803.3 define?

definition of manufacturer

What does FDA not consider mobile platform manufacturers to be?

medical device manufacturers

What is the term for providers of general-purpose computer or information technology?

providers

What is a creator of a mobile medical app or a software system that provides users access to the medical device function through a website subscription?

a mobile medical app or a software system

What does a licensed practitioner create that enables attaching an ECG el?

XYZ-recorder

What is not considered a mobile medical app manufacturer if Dr. XYZ is in a telehealth network?

Dr. XYZ is not considered a mobile medical apps manufacturer

What is the name of the document that contains the potential sources of Bias in a Retrospective Reader Study?

Potential Sources of Bias in a Retrospective Reader Study

What should not be necessary unless you intend to make specific performance claims?

Powering any additional units-based analyses for statistical significance

What does the “server software application” provide a service to?

a client software application on a mobile platform

What does 21 CFR 807.65(d) say?

“practitioners licensed by law to prescribe or administer drugs or devices and who manufacture, prepare, propagate, compound, or process drugs or devices solely for use in the course of their professional practice.”

What may be subject to investigational device exemption regulations?

human subjects

What does Appendix A provide examples of?

software functions

What is the Regulatory Approach for Device Software Functions?

V. Regulatory Approach for Device Software Functions

What is the FDA's approach to overseeing device software functions consistent with?

our existing approach

What does FDA believe a subset of device software functions poses the same or similar potential risks to the public health as currently regulated devices if they fail to function as intended?

risks

What must a manufacturer meet to make a device software function?

the requirements associated with the applicable device classification

What is the focus of FDA's regulatory oversight?

software functions

What is an extension of one or more medical devices by connecting37 to such device(s) for purposes of controlli?

Software functions

What is the Recall rate?

the percentage of patients (including diseased and non-diseased patients) that are called back or recalled for additional medical assessment

What is the criterion for not being physically connected to the regulated medical device?

device software functions or mobile medical apps

What is a software function that allows a user to control the delivery of insulin on an insulin pump by transmitting control signals to the pumps from the mobile platform?

mobile apps

What is FDA's guidance document for accessories to medical devices?

“Medical Device Accessories - Describing Accessories and Classification Pathways”39

What are software functions that use attachments, display screens, sensors, or other similar components required to comply with?

the device classification associated with the transformed platform

What is an ECG?

electrocardiograph

What does a software function that displays radiological images for diagnosis transform a mobile platform into?

Medical image management and processing system

What is a cardiac monitoring software classified as under 21 CFR 870.2300?

cardiac monitoring software

What is the 21 CFR 884.2740?

perinatal monitoring system

What is CAD?

image processing software

What is a software function that analyzes readings from a blood glucose monitor and alerts the user of readings outside a predetermined range?

software function

What is the name of the 2008 publication that was published by Radiol?

247(1):12–15

What does FDA encourage manufacturers of device software functions that perform patient- specific analysis to contact?

FDA

What does the CDS Guidance say can help users?

41 21 CFR 892.2050

What does FDA intend to exercise for software functions that pose a low risk to patients?

enforcement discretion

What are some software functions that coach patients with conditions such as cardiovascular disease, hypertension, diabetes, or obesity?

o Software functions that coach patients with conditions such as cardiovascular disease, hypertension, diabetes, or obesity

What is the sole responsibility of the health care professionals who have experience with them in medical applications?

the health care professionals who have experience with them in medical applications

What does an app use to supplement a verbal description in a consultation between health care professionals?

photos of a patient’s skin lesions or wounds

What is the software function intended to provide?

a convenient way for clinicians to perform various simple medical calculations taught in medical

What is the product code NXQ?

medication reminder is a device intended for medical purposes to provide alerts to patients or health care providers for pre-determined medication dosing schedules

What is the APGAR score?

Glasgow Coma Scale score

What is the name of the example of software functions for which FDA intends to exercise enforcement discretion?

Appendix B

What should be clarified and specify a version number if appropriate?

the software implementation

What is the associated regulation for the device software function?

associated controls

What is the name of the regulation that regulates the use of medical devices in the 21 CFR?

Quality System (QS)

What is the name of the nonbinding recommendation for Class III devices?

General Controls

What is the name of the branch that provides technical training to medical device manufacturers?

MATTB

What is the name of the Appendix that provides a representative list of software functions that are NOT Medical Devices?

Appendix A

What does FDA not regulate because these software functions are not considered medical devices?

them

What is not intended to be used as reference material and is not intended for use in the diagnosis of disease or other co Answer: These are not devices because the software is intended to be used as reference material and is not intended for use in the diagnosis of disease or other co Answer: Answer: The FDA does not consider to be devices because the software is intended to be used as reference material and is not intended for use in the diagnosis of disease or other co Answer: 1. Software functions that are intended to provide access to electronic “copies” (e.g., e-books, audio books) of medical textbooks or other reference materials with generic text search capabilities?

null