Funybubble/fda · Datasets at Hugging Face

Question stringlengths 13 1.05k ⌀	Answer stringlengths 2 801 ⌀
What should be used for computerized systems that contain any data that are relied on by an applicant in support of a marketing application?	principles outlined in this guidance
What is an example of a recorded source data transmitted from automated instruments directly to a computerized system?	chemistry autoanalyser
What is the purpose of the company's testing related to sterility and degradation?	g. Note that the company’s testing related to sterility and 337 degradation would primarily be intended to verify that the new process did not create 338 issues. the company’s testing related to sterility and 337 degradation
What does the guidance not apply to?	computerized medical devices that generate such data and that are otherwise regulated by FDA
What is IDE?	Notice of Claimed Investigational Exemption for a New Animal Drug
What is an example of a standard operating procedure that should be in place when using computerized systems to create, modify, maintain, or transmit electronic records?	inadvertently unblinding a study
What should be made available for use by personnel and for inspection by FDA?	SOPs
What is the requirement for source document retention?	retention of the original source document, or a copy of the source document
What should be maintained at another location?	a copy of the data
What should the system be designed to limit?	the number of log-in attempts
What should be changed at established intervals commensurate with a documented risk assessment?	passwords or other access keys
What is an example of a security measure that can prevent data entry until a password is entered?	an automatic screen saver
What can be used to verify the quality and integrity of data?	Computer-generated, time-stamped audit trails or other security measures
What is the tissue 349 plane in which the drug is delivered, changes to the rate of delivery, and changes in the 351 consistency of the combination product?	Changes in delivery include changes in the tissue 349 plane in which the drug is delivered, changes to the rate of delivery (because of 350 change in injection time between the PFS and autoinjector), and changes in the 351 consistency of the PK 348 profile
What is the pref What is the pref What is the pref What is the pref What is the pref What is the pref What is the pref What is the pref What is the pref What is the pref What is the pref Who should not be able to modify the documents or security measures used to track electronic record changes?	personnel who create, modify, or delete electronic records
What should describe when, by whom, and the reason changes were made to the electronic record?	Audit trails
What should be notified if a system date or time discrepancy is detected?	authorized personnel
What is the most likely use of computerized systems?	multi-center clinical trials
What should be put in place to ensure that access to the computerized system and to the data is restricted to authorized personnel?	external safeguards
What should be kept in the study documentation, accessible for use by appropriate study personnel and for inspection by FDA investigators?	That record should be kept in the study documentation
What is the main effect of computer viruses and worms on study data and software?	harmful software code
What should you do to avoid falsification of data?	perform a careful analysis
What should FDA describe and explain how source data were obtained and managed?	how electronic records were used to capture data
What should be retained as part of the study records and be available for inspection by FDA?	this documentation
What will the extent to which existing safety data or 352 effectiveness data can be bridged and leveraged depend on?	PK comparisons
What should be regularly backed up in a procedure that would prevent a catastrophic loss and ensure the quality and integrity of the data?	a procedure
What should be evaluated and some should be validated depending on risk?	Changes that exceed previously establishes
What should be documented?	all changes to the system
What should be documented for the purpose of this guidance?	computer education, training, and experience
What is a process that captures details such as additions, deletions, or alterations of information in an electronic record without obliterating the original record.?	null
What is a computerized system used for?	create, modify, maintain, archive, retrieve, or transmit in digital form information related to the conduct of a clinical trial
What are the values that represent the first recording of study data?	original data
What are some of the sources of original records?	hospital records, clinical and office charts, laboratory notes, memoranda, subjects' diaries or evaluation checklists
What is the purpose of a Transmit?	to transfer data within or among clinical study sites, contract research organizations, data management centers, sponsors, or to FDA
What is the FDA's Compliance Program Guidance Manual?	Compliance Program 7348.811 - Bioresearch Monitoring - Clinical Investigators
What is the design verification ensur?	Design validation ensur
What is the FDA's Part 11 of Electronic Records?	Electronic Records; Electronic Signatures — Scope and Application
What should the SOPs include, but are not limited to, the following processes?	The SOPs
What is the Guidance for the Content of Investigational Device Exemptions for Solutions for Hypothermic Flushing, Transport and Storage of Organs for Transplantation?	Guidance for the Content of Investigational Device Exemptions for Solutions for Hypothermic Flushing, Transport and Storage of Organs for Transplantation
What is the branch of Reproductive Abdominal and Radiological Devices that handles Renal Devices?	Division of Reproductive Abdominal and Radiological Devices Office of Device Evaluation Preface Public Comment Comments and suggestions may be submitted at any time for Agency consideration to Dockets Management Branch, Division of Management Systems and Policy, Office of Human Reso Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: FDA Reviewers Document issued on January 16, 2001 U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Gastroenterology and Renal Devices Branch Division of Reproductive Abdominal and Radiological Devices Office of Device Evaluation Preface Public Comment Comments and suggestions may be submitted at any
What is the name of the room in the Food and Drug Administration's guidance document?	Room 1061
What is the name of the telephone number that CDRH uses to send documents via fax?	301-827-0111
What is the pound sign for the nt number 1164?	pound
What is the Code of Federal Regulations?	Code of Federal Regulations
What is the name of the FDA's guidance document regarding IDEs?	Investorigational Device Exemptions Manual
What does this document not address?	preservation of the cornea
What is the name of the guidance for industry and FDA staff Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products?	Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products
What do we believe need to be addressed before your device can be approved for marketing?	issues identified in this guidance document
What is the least burdensome approach to resolving the issues presented in the guidance document?	we believe that we have considered the least burdensome approach
What is the FDA's recommendation for all IDEs for these products?	contain the information described on the following pages
What should be provided to demonstrate that the chemicals possess sufficient purity for use in this product?	adequate justification
What should be provided in lieu of biocompatibility testing?	Biological Evaluation of Medical Devices Part-1: Evaluation and Testing
What should be assessed after storage for specified time periods?	sterility (bacteria and endotoxin)
What will normally be necessary to demonstrate the safety of the solution and, possibly, to establish the appropriateness of surrogate endpoints that may be used in the clinical trial.?	null
What is the most important factor in selecting the animal model?	relevance to the ultimate clinical use of the product
What should the control be widely used for?	preservation of the organ in question
What do foreign sites not require?	IDE approval
What is the purpose of the concentration-time profile?	applicant intends to gather additional 359 information to evaluate clinical effect of these differences
What should be provided along with copies of all published or unpublished adverse information?	copies of all published or unpublished adverse information
What is the control solution currently in use at the investigational site?	heterogeneous control
What is the FDA's opinion on the use of trol?	The FDA believes that it would be appropriate to include data from at least one U.S. investigational site in the marketing application
How many sites should the study include?	4 at least three
What should be provided to the patient for removal from the study?	A complete listing of the inclusion/exclusion criteria
What is the primary endpoint of the study?	7 day graft survival
What are appropriate secondary endpoints for heart preservation solutions?	cardiac index, wedge pressure, need for inotropic drugs, biopsy results and time in ICU
What should be provided to FDA to discuss the issues of “extended” preservation time?	preservation times
What is the name of the Guidance for Clinical Trials of Non-Diagnostic Medical Devices?	null
What is the name of the Guidance for Industry and Food and Drug Administration Staff Addition of URLs to Electronic Product Labeling Document issued on: September 30 Guidance for Industry and Food and Drug Administration Staff?	null
What is the name of the branch of the Agency that provides electronic products?	Electronic Products Branch
What did the applicant not intend to modify?	device performance specifications
What is the address of the Division of Dockets Management?	5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852
What is the document number for guidance for Industry and Food and Drug Administration Staff?	1703
What is the FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA?	null
What does 21 CFR 1010.3(a)(1) and (2) require manufacturers to include on their electronic product labels?	full name and address and place, month and year of manufacture
What does FDA's guidance documents do not establish?	legally enforceable responsibilities
What is the month and year of manufacture on a product's identification tag or label?	21 CFR 1010.3(a)(1) and (2)
What does CDRH not recommend in instances where a manufacturer is unable to place its URL, in addition to the required full name and address and place, month and year of manufacture, on its current product label?	inclusion of the URL
What should a manufacturer point directly to when adding its URL to a product tag or label?	1. A web page where the manufacturer’s full name and current physical address are posted
What is one factor the Agency may consider in making such a determination?	The presence of the URL on the product label
What is the name of the organization that is responsible for the administration of the Ultrasound Stimulator System?	Food and Drug Administration Center for Devices and Radiological Health
What is the same in the route of administration?	the 374 same (subcutaneous)
What is the address of the Dockets Management Branch?	5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852
What is the name of the document that you are requesting?	1701
What is the name of the testing method used to determine the device's scope?	Scope
What is the acronym for Electrical and Mechanical Safety Performance Testing?	EMC
What is the name of the device that is used for aesthetic use?	Focused Ultrasound Stimulator System
What is the purpose of the focused ultrasound stimulator system?	for aesthetic use
What must a manufacturer who intends to market a device of this generic type conform to?	general controls of the Federal Food, Drug & Answer: (1) conform to the general controls of the Federal Food, Drug & Answer: evice
What is the FD&C Act?	21 CFR 807 Subpart E
What does the FDA identify and describe measures that if followed by manufacturers and combined with the Class II Special Controls Guidance Document general controls, will generally address the risks associated with focused ultrasound stimulator systems and lead to a timely 510(k) review?	null
What is a Focused Ultrasound Stimulator System for Aesthetic Use Identification?	a device using focused ultrasound to produce
What is the combination or bundle of multiple parallel detection schemes designed to detect?	one type of potential abnormality revealed in the patient radiological data
What was not changed by the modification of the autoinjector?	the user interface
What is the purpose of focused Ultrasound Stimulator System for Aesthetic Use?	Focused Ultrasound Stimulator System for Aesthetic Use
What do we recommend you identify within the scope of the 510(k)?	Device Components
What is the FDA's general view of evice and the predicate?	indications for use and technological characteristics
What should you do before submitting your premarket notification to identify other risks?	conduct a risk analysis
What should be demonstrated that the focused ultrasound stimulator system meets all design specification and performance requirements?	meets all design specification and performance requirements
What should be demonstrated by measurements of temperature distributions in vitro, such as in tissue mimicking materials, and via computational modeling of the thermal dose?	predictable thermal lesions
What should be addressed in testing to avoid cavitation and bubble formation?	possible cavitation and bubble formation either in the focal region or at the device-tissue interface

What should be used for computerized systems that contain any data that are relied on by an applicant in support of a marketing application?

principles outlined in this guidance

What is an example of a recorded source data transmitted from automated instruments directly to a computerized system?

chemistry autoanalyser

What is the purpose of the company's testing related to sterility and degradation?

g. Note that the company’s testing related to sterility and 337 degradation would primarily be intended to verify that the new process did not create 338 issues. the company’s testing related to sterility and 337 degradation

What does the guidance not apply to?

computerized medical devices that generate such data and that are otherwise regulated by FDA

What is IDE?

Notice of Claimed Investigational Exemption for a New Animal Drug

What is an example of a standard operating procedure that should be in place when using computerized systems to create, modify, maintain, or transmit electronic records?

inadvertently unblinding a study

What should be made available for use by personnel and for inspection by FDA?

SOPs

What is the requirement for source document retention?

retention of the original source document, or a copy of the source document

What should be maintained at another location?

a copy of the data

What should the system be designed to limit?

the number of log-in attempts

What should be changed at established intervals commensurate with a documented risk assessment?

passwords or other access keys

What is an example of a security measure that can prevent data entry until a password is entered?

an automatic screen saver

What can be used to verify the quality and integrity of data?

Computer-generated, time-stamped audit trails or other security measures

What is the tissue 349 plane in which the drug is delivered, changes to the rate of delivery, and changes in the 351 consistency of the combination product?

Changes in delivery include changes in the tissue 349 plane in which the drug is delivered, changes to the rate of delivery (because of 350 change in injection time between the PFS and autoinjector), and changes in the 351 consistency of the PK 348 profile

What is the pref What is the pref What is the pref What is the pref What is the pref What is the pref What is the pref What is the pref What is the pref What is the pref What is the pref Who should not be able to modify the documents or security measures used to track electronic record changes?

personnel who create, modify, or delete electronic records

What should describe when, by whom, and the reason changes were made to the electronic record?

Audit trails

What should be notified if a system date or time discrepancy is detected?

authorized personnel

What is the most likely use of computerized systems?

multi-center clinical trials

What should be put in place to ensure that access to the computerized system and to the data is restricted to authorized personnel?

external safeguards

What should be kept in the study documentation, accessible for use by appropriate study personnel and for inspection by FDA investigators?

That record should be kept in the study documentation

What is the main effect of computer viruses and worms on study data and software?

harmful software code

What should you do to avoid falsification of data?

perform a careful analysis

What should FDA describe and explain how source data were obtained and managed?

how electronic records were used to capture data

What should be retained as part of the study records and be available for inspection by FDA?

this documentation

What will the extent to which existing safety data or 352 effectiveness data can be bridged and leveraged depend on?

PK comparisons

What should be regularly backed up in a procedure that would prevent a catastrophic loss and ensure the quality and integrity of the data?

a procedure

What should be evaluated and some should be validated depending on risk?

Changes that exceed previously establishes

What should be documented?

all changes to the system

What should be documented for the purpose of this guidance?

computer education, training, and experience

What is a process that captures details such as additions, deletions, or alterations of information in an electronic record without obliterating the original record.?

null

What is a computerized system used for?

create, modify, maintain, archive, retrieve, or transmit in digital form information related to the conduct of a clinical trial

What are the values that represent the first recording of study data?

original data

What are some of the sources of original records?

hospital records, clinical and office charts, laboratory notes, memoranda, subjects' diaries or evaluation checklists

What is the purpose of a Transmit?

to transfer data within or among clinical study sites, contract research organizations, data management centers, sponsors, or to FDA

What is the FDA's Compliance Program Guidance Manual?

Compliance Program 7348.811 - Bioresearch Monitoring - Clinical Investigators

What is the design verification ensur?

Design validation ensur

What is the FDA's Part 11 of Electronic Records?

Electronic Records; Electronic Signatures — Scope and Application

What should the SOPs include, but are not limited to, the following processes?

The SOPs

What is the Guidance for the Content of Investigational Device Exemptions for Solutions for Hypothermic Flushing, Transport and Storage of Organs for Transplantation?

Guidance for the Content of Investigational Device Exemptions for Solutions for Hypothermic Flushing, Transport and Storage of Organs for Transplantation

What is the branch of Reproductive Abdominal and Radiological Devices that handles Renal Devices?

Division of Reproductive Abdominal and Radiological Devices Office of Device Evaluation Preface Public Comment Comments and suggestions may be submitted at any time for Agency consideration to Dockets Management Branch, Division of Management Systems and Policy, Office of Human Reso Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: Answer: FDA Reviewers Document issued on January 16, 2001 U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Gastroenterology and Renal Devices Branch Division of Reproductive Abdominal and Radiological Devices Office of Device Evaluation Preface Public Comment Comments and suggestions may be submitted at any

What is the name of the room in the Food and Drug Administration's guidance document?

Room 1061

What is the name of the telephone number that CDRH uses to send documents via fax?

301-827-0111

What is the pound sign for the nt number 1164?

pound

What is the Code of Federal Regulations?

Code of Federal Regulations

What is the name of the FDA's guidance document regarding IDEs?

Investorigational Device Exemptions Manual

What does this document not address?

preservation of the cornea

What is the name of the guidance for industry and FDA staff Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products?

Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products

What do we believe need to be addressed before your device can be approved for marketing?

issues identified in this guidance document

What is the least burdensome approach to resolving the issues presented in the guidance document?

we believe that we have considered the least burdensome approach

What is the FDA's recommendation for all IDEs for these products?

contain the information described on the following pages

What should be provided to demonstrate that the chemicals possess sufficient purity for use in this product?

adequate justification

What should be provided in lieu of biocompatibility testing?

Biological Evaluation of Medical Devices Part-1: Evaluation and Testing

What should be assessed after storage for specified time periods?

sterility (bacteria and endotoxin)

What will normally be necessary to demonstrate the safety of the solution and, possibly, to establish the appropriateness of surrogate endpoints that may be used in the clinical trial.?

null

What is the most important factor in selecting the animal model?

relevance to the ultimate clinical use of the product

What should the control be widely used for?

preservation of the organ in question

What do foreign sites not require?

IDE approval

What is the purpose of the concentration-time profile?

applicant intends to gather additional 359 information to evaluate clinical effect of these differences

What should be provided along with copies of all published or unpublished adverse information?

copies of all published or unpublished adverse information

What is the control solution currently in use at the investigational site?

heterogeneous control

What is the FDA's opinion on the use of trol?

The FDA believes that it would be appropriate to include data from at least one U.S. investigational site in the marketing application

How many sites should the study include?

4 at least three

What should be provided to the patient for removal from the study?

A complete listing of the inclusion/exclusion criteria

What is the primary endpoint of the study?

7 day graft survival

What are appropriate secondary endpoints for heart preservation solutions?

cardiac index, wedge pressure, need for inotropic drugs, biopsy results and time in ICU

What should be provided to FDA to discuss the issues of “extended” preservation time?

preservation times

What is the name of the Guidance for Clinical Trials of Non-Diagnostic Medical Devices?

null

What is the name of the Guidance for Industry and Food and Drug Administration Staff Addition of URLs to Electronic Product Labeling Document issued on: September 30 Guidance for Industry and Food and Drug Administration Staff?

null

What is the name of the branch of the Agency that provides electronic products?

Electronic Products Branch

What did the applicant not intend to modify?

device performance specifications

What is the address of the Division of Dockets Management?

5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852

What is the document number for guidance for Industry and Food and Drug Administration Staff?

1703

What is the FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA issuing t Answer: FDA?

null

What does 21 CFR 1010.3(a)(1) and (2) require manufacturers to include on their electronic product labels?

full name and address and place, month and year of manufacture

What does FDA's guidance documents do not establish?

legally enforceable responsibilities

What is the month and year of manufacture on a product's identification tag or label?

21 CFR 1010.3(a)(1) and (2)

What does CDRH not recommend in instances where a manufacturer is unable to place its URL, in addition to the required full name and address and place, month and year of manufacture, on its current product label?

inclusion of the URL

What should a manufacturer point directly to when adding its URL to a product tag or label?

1. A web page where the manufacturer’s full name and current physical address are posted

What is one factor the Agency may consider in making such a determination?

The presence of the URL on the product label

What is the name of the organization that is responsible for the administration of the Ultrasound Stimulator System?

Food and Drug Administration Center for Devices and Radiological Health

What is the same in the route of administration?

the 374 same (subcutaneous)

What is the address of the Dockets Management Branch?

5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852

What is the name of the document that you are requesting?

1701

What is the name of the testing method used to determine the device's scope?

Scope

What is the acronym for Electrical and Mechanical Safety Performance Testing?

EMC

What is the name of the device that is used for aesthetic use?

Focused Ultrasound Stimulator System

What is the purpose of the focused ultrasound stimulator system?

for aesthetic use

What must a manufacturer who intends to market a device of this generic type conform to?

general controls of the Federal Food, Drug & Answer: (1) conform to the general controls of the Federal Food, Drug & Answer: evice

What is the FD&C Act?

21 CFR 807 Subpart E

What does the FDA identify and describe measures that if followed by manufacturers and combined with the Class II Special Controls Guidance Document general controls, will generally address the risks associated with focused ultrasound stimulator systems and lead to a timely 510(k) review?

null

What is a Focused Ultrasound Stimulator System for Aesthetic Use Identification?

a device using focused ultrasound to produce

What is the combination or bundle of multiple parallel detection schemes designed to detect?

one type of potential abnormality revealed in the patient radiological data

What was not changed by the modification of the autoinjector?

the user interface

What is the purpose of focused Ultrasound Stimulator System for Aesthetic Use?

Focused Ultrasound Stimulator System for Aesthetic Use

What do we recommend you identify within the scope of the 510(k)?

Device Components

What is the FDA's general view of evice and the predicate?

indications for use and technological characteristics

What should you do before submitting your premarket notification to identify other risks?

conduct a risk analysis

What should be demonstrated that the focused ultrasound stimulator system meets all design specification and performance requirements?

meets all design specification and performance requirements

What should be demonstrated by measurements of temperature distributions in vitro, such as in tissue mimicking materials, and via computational modeling of the thermal dose?

predictable thermal lesions

What should be addressed in testing to avoid cavitation and bubble formation?

possible cavitation and bubble formation either in the focal region or at the device-tissue interface