Funybubble/fda · Datasets at Hugging Face

Question stringlengths 13 1.05k ⌀	Answer stringlengths 2 801 ⌀
What should be consistent with the general approach used for evaluation of PI content?	FDA’s assessment of the prescription drug use-related software-related information
What does the placement and extent of information describing 217 software functions in the PI depend on?	the evidence submitted by the sponsor and whether the 218 software functions are device-connected
What may demonstrate that a combination product 229 with device-connected prescription results in a meaningful improvement in a clinical outcome?	evidence
What is a dose-tracking app?	a meaningful change in a clinical outcome or validated surrogate endpoint
What is an acceptable non-fully crossed study design?	non-fully crossed study designs
What should be reviewed and approved by FDA as is required for 24 See 21 CFR 314.126(b)?	null
What is the following 255 Answer: In many cases, a sponsor may develop prescription drug use-related software that relies on data 252 directly transferred from the device constituent part of a drug sponsor’s combination product without generating evidence showing that use of the prescription drug use-related software 254 confers additional clinical benefit beyond that of the combination product alone.?	null
What is a sponsor's proposal to include in the PI about the inhaler's ability to track inhaler events?	a brief 261 description
What is a sponsor 266 responsible for?	develop an autoinjector that captures when the autoinjector is used and transfers that 267 information to a mobile app
What does the prescription drug use-related software relies on in these examples?	data directly 272 transferred from the device constituent part of the combination product
What should the PI provide in 277?	a brief description 278 of the device constituent part and the associated software function(s)
What may be submitted in an annual report if the information is consistent with 21 CFR 314.70(d)(2).?	null
What would the end-user output from prescription drug use-related software generally be considered?	promotional labeling
What must be submitted to FDA by the applicant at the time of initial dissemination?	Form FDA 2253 (Transmittal of Advertisements and Promotional Labeling 296 for Drugs and Biologics for Human Use)
What is the voluntary opportunity to submit promotional communications to FDA?	21 CFR 202.1(j)(4)
What is a key factor for obtaining consistent and convincing scientific evidence?	specification of the statistical analysis
Who will CDRH consult with regarding the representations about the drug within the prescription drug use-related software?	CDER or CBER
What must applicants submit at the time of initial dissemination?	Form FDA 2253
What is the case of cleared devices?	could significantly affect the safety or effectiveness of the device
What is the requirement for a new or modified device constituent part or component of a combination product?	a new or modified device constituent part or component of a combination product
What does Example A's network-connected mobile app display on a screen via the mobile app?	data 325
What is the data showing over time displayed on?	ingestion over time
What are the five software functions considered?	device-connected software functions 340
What is the end-user output of the web-application?	display of ingestion data
What does the Example B mobile app transfer the self-reported information to?	a cloud-based application for their health 354 care practitioner to review on a web-application
What is the name of the software function that allows the display of symptom 360 incidence and severity data via the mobile app display screen?	software
What is the rating scale used for?	Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: the selected case sample size, o statistical and clinical justification of the selected number of readers
What is the end-user output of the web-application?	display of self-reported information
What is the example C intended to be used with?	a combination product
What does the 380 patient mobile app transfer the self-reported 382 data to?	the health care practitioner web-application
What is the web-application used to aggregate?	self- 384 reported symptoms data and the data collected from the device constituent part of the 385 combination product
What is the transfer of notifications and alerts to a health care 394 practitioner web-application?	the transfer of notifications and alerts
What is the transfer of patient- 398 self reported data to the health care practitioner web-application?	transfer of patient- 398 self reported data
What are the four end-user outputs?	the web-application’s display of data
What is the patient mobile app's display of data collected from the device constituent part of the combination 414 product?	patient mobile 413 app
What is the software included in the mobile app?	dose calculator function
What is the output determined to be for the prescription drug?	promotional labeling
What is the details of the scoring technique used?	Section IV.E. Scoring
What does the changes do that do not affect the clinical use of the device?	do 435 not affect the clinical use of the device
What does the mobile app mention?	sponsor’s drug name
What does the welcome video include information on?	the safety and effectiveness of the 447 insulin product but does not provide information on the dose calculator
What is the most recent version of a guidance?	FDA guidance web page
What must be submitted on Form FDA 2253 at the time of 452 initial dissemination?	revised output
What is the name of the end user that the prescription drug use-related software presents to the end user?	a patient, caregiver, or health care practitioner
What does software function 468 rely on?	data directly transferred from the device constituent part of a sponsor’s combination 469 product
What is the name of the document that provides guidance for industry and Food and Drug Administration Staff?	Guidance for Industry and Food and Drug Administration Staff Document
What is the docket number of FDA-2018-D-1774?	FDA-2018-D-1774
What is the document number of the guidance?	16016
What is the name of the study that is the subject of the book?	Evaluation Paradigm and Study Endpoints
What is appropriately representative of the intended use population?	study populations
What does the guidance not establish any rights for?	any pers
What is the purpose of this guidance document?	to provide recommendations for information to Answer: The purpose of this guidance document is to provide recommendations for information to Answer: Answer: This guidance document addresses labeling considerations for devices containing lubricious coatings used in the vasculature
What is the name of the premarket notification submission that is submitted in the labeling of a device?	510(k)s
What is the name of the coating that devices often have to reduce friction between devices?	polyvinylpyrrolidone (PVP), polytetrafluoroethylene (PTFE), silicone
What are hydrophilic and hydrophobic coated devices used for?	more than 20 yea
What does the FDA believe may separate from intravascular devices in some circumstances?	coating
What is the name of the document that describes the separation of hydrophilic and/or hydrophobic coatings from medical devices?	Medical Device Reports
What has the FDA evaluated in relation to ducers?	peer-reviewed medical literature1,2,3,4 and physician surveys
What did some patients require to mitigate the consequences of coating fragments?	surgical intervention
What is the purpose of the communication?	to make health care providers aware of the possibility that hydrophilic and/or hydrophobic coatings may separate from medical devices
What is the purpose of study endpoints?	to demonstrate that your CADe device is effective
What was the name of the device used to treat supraclinoid aneurysms?	Pipeline Embolization Device
What is the Human Pathology, 2015?	46(3): 488-489
What is the FDA not suggesting is associated with higher risks than others?	any specific manufacturer or brand of these devices
What is the FDA guidance titled?	Non- Clinical Engineering Tests and Recommended Labeling for Intravascular Answer: Non- Clinical Engineering Tests and Recommended Labeling for Intravascular Answer: Non- Clinical Engineering Tests and Recommended Labeling for Intravascular Answer: Intravascular Answer: Non- Clinical Engineering Tests and Recommended Labeling for Intravascular Answer: Non- Clinical Engineering Tests and Recommended Labeling for Intravascular Answer: Non- Clinical Engineering Tests and Recommended Labeling for Intravascular Answer: Non- Clinical Engineering Tests and Recommended Labeling for Intravascular Answer: Non- Clinical Engineering Tests and Recommended Labeling for Intravascular Answer: Non- Clinical Engineering Tests and Recommended Labeling for Intravascular Answer: Non- Clinical Engineering Tests
What is the name of the guidance document that provides labeling recommendations for intravascular catheters and wires?	Labeling recommendations for both Class III and Class II devices
What are the devices in the scope of this guidance?	a variety of devices and product codes
What is the Regulation Number of the DQO Catheter?	Regulation Number DQO Catheter, Intravascular, Diagnostic
What is the term for the Term Greater Than 30 Days LJT Port & Catheter?	Term
What is the current product code of the device for Acute Ischemic Stroke Treatment?	870.133
What is the receiver operating characteristic (FROC) curve?	free-response receiver operating characteristic (FROC) curve
What is the name of the table that shows the classification of Class III devices?	Table 2
What is PTCA?	nal Coronary Angioplasty
What are the recommendations based on?	known safety issues
What is the name of the FDA guidance on deciding when to submit a 510(k) for a change to an existing device?	“Deciding When to Submit a 510(k) for a Change to an Existing Device,”9
What should the device description prominently note the presence of?	the coating
What should all indications for use described in the labeling be supported by?	information in the premarket submission
What are many devices designed, labeled, and indicated for?	specific uses
What is the name of the document that should be included in the labeling of a device?	precaution statement
What should include information that will guide the user in a clinical setting?	The preparation steps
What should you include if you believe one or more of the considerations are not applicable to your device?	any additional warnings and precautions not identified below that you determine are necessary to promote the safe use of the device based on your device design and intended use
What is the LROC curve?	sensitivity (Se) and specificity (Sp)
What is a warning against reuse or re-sterilization of the device?	reuse or re-sterilization of the device
What is the recommended duration for pre-conditioning?	appropriate duration
What should a user do if they have a known incompatibility with specific media or solvents?	specification of any known incompatibility
What should the labeling instruct and warn users to do?	use caution when manipulating, advancing and/or withdrawing these devices
What may result in adverse events (section D below) requiring additional intervention?	coating material remaining in the vasculature
What is important to the user to be informed of?	key device dimensions
What is the term for aqueous media in which a coating swells?	saline
What should be presented in a format consistent with 21 CFR 801.18?	The date
What should be avoided during preparation or device use that could result in misuse scenarios or coating damage be identified?	Any practices that should be avoided during preparation or device use
What should the labeling instruct the user of?	appropriate shape configurations and shaping
What is the probability that a test is negative for a population of normal patients?	Sp
What should the user do if the device should not move freely?	exercise caution when removing the device and/or other components as a unit
What may depend on the specific design?	specific adverse events
What are some of the adverse events that may occur at the access site?	Sterile inflammation or granulomas
When was the original document issued?	September 25, 2013
What is the name of the facility that Food and Drug Administration Center for Devices and Radiological Health Center for Biologics Evaluation and Research is located in?	U.S. Department of Health and Human Services
What is the OCOD?	Office of Communication, Outreach, and Development
What does FDA intend to exercise for software functions?	enforcement discretion

What should be consistent with the general approach used for evaluation of PI content?

FDA’s assessment of the prescription drug use-related software-related information

What does the placement and extent of information describing 217 software functions in the PI depend on?

the evidence submitted by the sponsor and whether the 218 software functions are device-connected

What may demonstrate that a combination product 229 with device-connected prescription results in a meaningful improvement in a clinical outcome?

evidence

What is a dose-tracking app?

a meaningful change in a clinical outcome or validated surrogate endpoint

What is an acceptable non-fully crossed study design?

non-fully crossed study designs

What should be reviewed and approved by FDA as is required for 24 See 21 CFR 314.126(b)?

null

What is the following 255 Answer: In many cases, a sponsor may develop prescription drug use-related software that relies on data 252 directly transferred from the device constituent part of a drug sponsor’s combination product without generating evidence showing that use of the prescription drug use-related software 254 confers additional clinical benefit beyond that of the combination product alone.?

null

What is a sponsor's proposal to include in the PI about the inhaler's ability to track inhaler events?

a brief 261 description

What is a sponsor 266 responsible for?

develop an autoinjector that captures when the autoinjector is used and transfers that 267 information to a mobile app

What does the prescription drug use-related software relies on in these examples?

data directly 272 transferred from the device constituent part of the combination product

What should the PI provide in 277?

a brief description 278 of the device constituent part and the associated software function(s)

What may be submitted in an annual report if the information is consistent with 21 CFR 314.70(d)(2).?

null

What would the end-user output from prescription drug use-related software generally be considered?

promotional labeling

What must be submitted to FDA by the applicant at the time of initial dissemination?

Form FDA 2253 (Transmittal of Advertisements and Promotional Labeling 296 for Drugs and Biologics for Human Use)

What is the voluntary opportunity to submit promotional communications to FDA?

21 CFR 202.1(j)(4)

What is a key factor for obtaining consistent and convincing scientific evidence?

specification of the statistical analysis

Who will CDRH consult with regarding the representations about the drug within the prescription drug use-related software?

CDER or CBER

What must applicants submit at the time of initial dissemination?

Form FDA 2253

What is the case of cleared devices?

could significantly affect the safety or effectiveness of the device

What is the requirement for a new or modified device constituent part or component of a combination product?

a new or modified device constituent part or component of a combination product

What does Example A's network-connected mobile app display on a screen via the mobile app?

data 325

What is the data showing over time displayed on?

ingestion over time

What are the five software functions considered?

device-connected software functions 340

What is the end-user output of the web-application?

display of ingestion data

What does the Example B mobile app transfer the self-reported information to?

a cloud-based application for their health 354 care practitioner to review on a web-application

What is the name of the software function that allows the display of symptom 360 incidence and severity data via the mobile app display screen?

software

What is the rating scale used for?

Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: Rating Scal Answer: the selected case sample size, o statistical and clinical justification of the selected number of readers

What is the end-user output of the web-application?

display of self-reported information

What is the example C intended to be used with?

a combination product

What does the 380 patient mobile app transfer the self-reported 382 data to?

the health care practitioner web-application

What is the web-application used to aggregate?

self- 384 reported symptoms data and the data collected from the device constituent part of the 385 combination product

What is the transfer of notifications and alerts to a health care 394 practitioner web-application?

the transfer of notifications and alerts

What is the transfer of patient- 398 self reported data to the health care practitioner web-application?

transfer of patient- 398 self reported data

What are the four end-user outputs?

the web-application’s display of data

What is the patient mobile app's display of data collected from the device constituent part of the combination 414 product?

patient mobile 413 app

What is the software included in the mobile app?

dose calculator function

What is the output determined to be for the prescription drug?

promotional labeling

What is the details of the scoring technique used?

Section IV.E. Scoring

What does the changes do that do not affect the clinical use of the device?

do 435 not affect the clinical use of the device

What does the mobile app mention?

sponsor’s drug name

What does the welcome video include information on?

the safety and effectiveness of the 447 insulin product but does not provide information on the dose calculator

What is the most recent version of a guidance?

FDA guidance web page

What must be submitted on Form FDA 2253 at the time of 452 initial dissemination?

revised output

What is the name of the end user that the prescription drug use-related software presents to the end user?

a patient, caregiver, or health care practitioner

What does software function 468 rely on?

data directly transferred from the device constituent part of a sponsor’s combination 469 product

What is the name of the document that provides guidance for industry and Food and Drug Administration Staff?

Guidance for Industry and Food and Drug Administration Staff Document

What is the docket number of FDA-2018-D-1774?

FDA-2018-D-1774

What is the document number of the guidance?

16016

What is the name of the study that is the subject of the book?

Evaluation Paradigm and Study Endpoints

What is appropriately representative of the intended use population?

study populations

What does the guidance not establish any rights for?

any pers

What is the purpose of this guidance document?

to provide recommendations for information to Answer: The purpose of this guidance document is to provide recommendations for information to Answer: Answer: This guidance document addresses labeling considerations for devices containing lubricious coatings used in the vasculature

What is the name of the premarket notification submission that is submitted in the labeling of a device?

510(k)s

What is the name of the coating that devices often have to reduce friction between devices?

polyvinylpyrrolidone (PVP), polytetrafluoroethylene (PTFE), silicone

What are hydrophilic and hydrophobic coated devices used for?

more than 20 yea

What does the FDA believe may separate from intravascular devices in some circumstances?

coating

What is the name of the document that describes the separation of hydrophilic and/or hydrophobic coatings from medical devices?

Medical Device Reports

What has the FDA evaluated in relation to ducers?

peer-reviewed medical literature1,2,3,4 and physician surveys

What did some patients require to mitigate the consequences of coating fragments?

surgical intervention

What is the purpose of the communication?

to make health care providers aware of the possibility that hydrophilic and/or hydrophobic coatings may separate from medical devices

What is the purpose of study endpoints?

to demonstrate that your CADe device is effective

What was the name of the device used to treat supraclinoid aneurysms?

Pipeline Embolization Device

What is the Human Pathology, 2015?

46(3): 488-489

What is the FDA not suggesting is associated with higher risks than others?

any specific manufacturer or brand of these devices

What is the FDA guidance titled?

Non- Clinical Engineering Tests and Recommended Labeling for Intravascular Answer: Non- Clinical Engineering Tests and Recommended Labeling for Intravascular Answer: Non- Clinical Engineering Tests and Recommended Labeling for Intravascular Answer: Intravascular Answer: Non- Clinical Engineering Tests and Recommended Labeling for Intravascular Answer: Non- Clinical Engineering Tests and Recommended Labeling for Intravascular Answer: Non- Clinical Engineering Tests and Recommended Labeling for Intravascular Answer: Non- Clinical Engineering Tests and Recommended Labeling for Intravascular Answer: Non- Clinical Engineering Tests and Recommended Labeling for Intravascular Answer: Non- Clinical Engineering Tests and Recommended Labeling for Intravascular Answer: Non- Clinical Engineering Tests

What is the name of the guidance document that provides labeling recommendations for intravascular catheters and wires?

Labeling recommendations for both Class III and Class II devices

What are the devices in the scope of this guidance?

a variety of devices and product codes

What is the Regulation Number of the DQO Catheter?

Regulation Number DQO Catheter, Intravascular, Diagnostic

What is the term for the Term Greater Than 30 Days LJT Port & Catheter?

Term

What is the current product code of the device for Acute Ischemic Stroke Treatment?

870.133

What is the receiver operating characteristic (FROC) curve?

free-response receiver operating characteristic (FROC) curve

What is the name of the table that shows the classification of Class III devices?

Table 2

What is PTCA?

nal Coronary Angioplasty

What are the recommendations based on?

known safety issues

What is the name of the FDA guidance on deciding when to submit a 510(k) for a change to an existing device?

“Deciding When to Submit a 510(k) for a Change to an Existing Device,”9

What should the device description prominently note the presence of?

the coating

What should all indications for use described in the labeling be supported by?

information in the premarket submission

What are many devices designed, labeled, and indicated for?

specific uses

What is the name of the document that should be included in the labeling of a device?

precaution statement

What should include information that will guide the user in a clinical setting?

The preparation steps

What should you include if you believe one or more of the considerations are not applicable to your device?

any additional warnings and precautions not identified below that you determine are necessary to promote the safe use of the device based on your device design and intended use

What is the LROC curve?

sensitivity (Se) and specificity (Sp)

What is a warning against reuse or re-sterilization of the device?

reuse or re-sterilization of the device

What is the recommended duration for pre-conditioning?

appropriate duration

What should a user do if they have a known incompatibility with specific media or solvents?

specification of any known incompatibility

What should the labeling instruct and warn users to do?

use caution when manipulating, advancing and/or withdrawing these devices

What may result in adverse events (section D below) requiring additional intervention?

coating material remaining in the vasculature

What is important to the user to be informed of?

key device dimensions

What is the term for aqueous media in which a coating swells?

saline

What should be presented in a format consistent with 21 CFR 801.18?

The date

What should be avoided during preparation or device use that could result in misuse scenarios or coating damage be identified?

Any practices that should be avoided during preparation or device use

What should the labeling instruct the user of?

appropriate shape configurations and shaping

What is the probability that a test is negative for a population of normal patients?

Sp

What should the user do if the device should not move freely?

exercise caution when removing the device and/or other components as a unit

What may depend on the specific design?

specific adverse events

What are some of the adverse events that may occur at the access site?

Sterile inflammation or granulomas

When was the original document issued?

September 25, 2013

What is the name of the facility that Food and Drug Administration Center for Devices and Radiological Health Center for Biologics Evaluation and Research is located in?

U.S. Department of Health and Human Services

What is the OCOD?

Office of Communication, Outreach, and Development

What does FDA intend to exercise for software functions?

enforcement discretion