Funybubble/fda · Datasets at Hugging Face

Question stringlengths 13 1.05k ⌀	Answer stringlengths 2 801 ⌀
What is the compliance date for Finished class I and unclassified devices?	September 24, 2018
What is the Compliance Policy for GUDID Submission Requirements for Class I Devices 1?	Compliance Policy for GUDID Submission Requirements for Class I Devices 1. Class I Devices Considered Consumer Health Products
What does “consumer health products” mean?	510(k)-exempt class I devices that are sold directly to consumers over-the-counter in brick-and-mortar and/or online stores and that do not fall within one or more of the categories
What is the policy for 2020 UDI Compliance Policy Guidance?	85 FR 39477
What is a biological product regulated under section 351 of the Public Health Service Act?	a drug or a device
What is the name of the agency that determines that class I devices are not considered consumer health products?	FDA
What are er risk devices subject to?	additional regulatory controls
What is the majority of class I devices exempt from?	the 510(k) premarket notification process
What is a clinical labora?	a clinical labora
What is the name of the subpart B of 21 CFR 801.40?	21 CFR 801.40
What is the name of the UDI that a user can use in addition to a UPC?	UDI
What is the definition of a prescription use?	prescription use
What is a life-supporting or life-sustaining device defined at 21 CFR 860.3 as?	a device that is “essential to, or that yie Answer: Life-supporting or life-sustaining device”
What does FDA recommend evaluating to determine if a particular device is life-supporting or life-sustaining?	the device’s intended use
What is the purpose of reusable vices?	intended for use by healthcare professionals only
What is the PFS for the PFS, elastomeric plunger, and needle?	the PFS
What is the term for a device that is intended to be used more than once on or by the same patient?	reusable
What does an unclassified device generally require?	submission of a 510(k) premarket notification
How many calendar days are required to submit a GUDID submission under 21 CFR 830.300 for unclassified devices?	75 calendar days
What is the direct mark compliance date for LS/LS devices?	September 24, 2015
What is the purpose of this provision?	reduce burden associated with the UDI Rule for inventories of finished devices that were manufactured and labeled prior to the applicable compliance date
What is the name of the guidance that describes the intention to exempt certain Unclassified Medical Devices from Premarket Notification Requirements?	“Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements”
What does the UDI Compliance Policy Guidance state that we do not intend to enforce the GUDID data submission requirements for?	unclassified devices
What is the name of the document that may be applicable to UDI?	tem/udi-exceptions-alternatives- and-time-extensions
What do labelers use the new field(s) to document when the field becomes available?	that their devices are subject to such a method
What is the ompliance date for class I and unclassified devices?	September 24, 2020
What is the step of the applicant that considers whether other existing information may be leveraged to 295 support the items in Step 4?	Step 4
What is the ark requirements under 21 CFR 801.45 for?	finished class I and unclassified devices
What is FDA looking for in a method for constructing the UDI?	documented or referenced that method in the DMR
What is the policy for UDI direct mark requirements under 21 CFR 801.45 for class I and unclassified devices, other than LS/LS devices, remains the same as the policy in the 2020 UDI Compliance Policy Guidance.?	null
What is the name of the FDA's Office of the Commissioner?	Office of the Commissioner
What is the name of the office of Communication, Education, and Radiation Programs Division of Small Manufacturers, International, and Consumer Assistance Center for Devices and Radiological Health?	Office of Communication, Education, and Radiation Programs
What is the name of the veterinary clinic in the US?	HFV-12
What is the name of the system that stores data?	Retrieving Data 6
What does not create or confer any rights for or on any person and does not operate to bind FDA or the public.?	null
What is the name of the FDA staff that implements this guidance?	FDA staff
What is the applicant considering establishing between the previously approved 302 product and the proposed autoinjector?	a bridge
What is the source data needed for?	the reconstruction and evaluation of the study to determine the safety of food and color additives and safety and effectiveness of new human and animal drugs,3 and medical devices
What is the name of the guidance that was issued in April 1999?	Electronic Records; Electronic Signatures — Scope and Application
What does the Agency intend to do with part 11?	interpret the scope of part 11 narrowly and to exercise enforcement discretion with regard to part 11 requirements for validation, audit trails, record retention, and record copying
What does the word should mean in Agency guidances?	something is suggested or recommended, but not required
What must be the same fundamental elements of data quality as paper records?	attributable, legible, contemporaneous, original,5 and accurate
What did FDA say was acceptable under certain circumstances?	electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records and handwritten signatures executed on paper
What was the final draft guidance for industry entitled?	Computerized Systems Used in Clinical Trials
What is allowing original documents to be replaced by copies?	copies
What does this guidance apply to computerized systems that capture analytical results of tests conducted during a clinical trial?	21 CFR 312.62(b) and 812.140(b)
What is an example of a computerized system that can be used to record an ECG reading?	an ECG reading
What is the purpose of the HF validation study?	it will be challenging to bridge the applications
What is IDE?	Investigational Device Exemption
What should the computerized systems do?	(1) to prevent errors in data creation, modification, maintenance, archiving, retrieval, or transmission
What should be maintained either on-site or be remotely accessible through electronic files as part of the specific study records?	SOPs
What is the source document when original observations are entered directly into a computerized system?	the electronic record
What is the name of the system that a data is entered directly into a remote computerized system?	a remote computerized system
What must be limited to authorized individuals?	Limited Access Access
What should individuals work only under?	their own password or other access key and not share these with others
What should someone do when they leave a workstation?	log off the system
What does the use of audit trails help to ensure?	only authorized additions, deletions, or alterations of information in the electronic record have occurred
What should be determined based on a justified and documented risk assessment?	The need for audit trails
What did the applicant believe it could leverage because of the previously approved autoinjector design?	design verification data unrelated to the drug being injected
What should describe when, by whom, and the reason changes were made to electronic record activities?	Audit trails or other security methods
Who should be notified if a system date or time discrepancy is detected?	authorized personnel
What do systems recommend that dates and times include?	year, month, day, hour, and minute
What is better for systems that span different time zones?	time stamps
What should be put in place to prevent the altering, browsing, querying, or reporting of data via external software applications that do not enter through the protective system software.?	null
What should be kept in the study documentation?	that record
What can be used to permit repopulation of information specific to the subject?	programming features
What should be designed in a way that retrieved data regarding each individual subject in a study is attributable to that subject?	computerized system
What is not necessary to reprocess data from a study that can be fully reconstructed from available documentation?	actual application software, operating systems, and software development tools
What should be designed to protect against data loss?	sufficient backup and recovery procedures
What is the applicant planning to provide design validation confirming?	that the autoinjector 323 performance specifications are adequate
Where should records be stored?	at a secure location
What should be documented for changes that exceed previously established operational limits or design specifications?	Changes that exceed previously established operational limits or design specifications
What should be provided to individuals in the specific operations with regard to computerized systems that they are to perform?	Training
What is a process that captures details such as additions, deletions, or alterations of information in an electronic record?	Audit Trail
What is an example of a computerized system?	user manual
What is an electronic record?	any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained
What is allowing original documents and the original data recorded on those documents to be replaced by copies?	copies
What is the purpose of a Transmit?	to transfer data within or Answer: Answer: at the pharmacy, at the laboratories, and at medico-technical departments involved in a clinical trial
What is the name of the guideline for the Monitoring of Clinical Investigations?	Guideline for the Monitoring of Clinical Investigations
What should the SOPs include?	System setup/installation
What is the OEB?	lung computed tomography system, computer-aided detection
What is the name of the document that contains nonbinding recommendations Draft—Not for Implementation?	21 CFR 820.30(g) & (j)
What is the name of the system maintenance?	System decommissioning
What is the name of the agency that oversees the use of computerized systems in clinical trials?	Office of the Commissioner
What is the phone number for the Drug Information Center for Drug Evaluation and Research?	301-827-4573
What is the name of the veterinary center that is located in the US?	HFV-12 Center for Veterinary Medicine
What is the name of the office that oversees the Food and Drug Administration?	Office of the Commissioner
What does the guidance represent?	the Food and Drug Administration's (FDA's) current thinking on this topic
What is the FDA's staff responsible for implementing?	this guidance
What are CROs?	data management centers
What is the name of the guidance dated April 1999?	Part 11
What is the purpose of the local adverse event data?	assess how the new interface may affect pain on delivery
What is the ICH E6 Good Clinical Practice consol?	Answer: Answer: ICH E6 Good Clinical Practice consol
What are the terms used in FDA guidance to describe the same information?	source documents
What does ICH stand for?	International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
What is an increasing use of computerized systems in clinical trials to generate and maintain source data and source documentation on each clinical trial subject?	computerized systems
What is the requirement for FDA's acceptance of data from clinical trials for decision-making purposes?	FDA's ability to verify the quality and integrity of the data during FDA on-site inspections and audits
What did FDA and industry want to do with part 11?	proposeing additional rulemaking, and exercising enforcement discretion regarding enforcement of certain part 11 requirements
What is the final version of the draft guidance for industry entitled Electronic Records; Electronic Signatures – Scope and Application (Scope and Application Guidance) dated August 2003.?	null
What is the approach outlined in the Scope and Application Guidance?	The approach outlined in the Scope and Application Guidance

What is the compliance date for Finished class I and unclassified devices?

September 24, 2018

What is the Compliance Policy for GUDID Submission Requirements for Class I Devices 1?

Compliance Policy for GUDID Submission Requirements for Class I Devices 1. Class I Devices Considered Consumer Health Products

What does “consumer health products” mean?

510(k)-exempt class I devices that are sold directly to consumers over-the-counter in brick-and-mortar and/or online stores and that do not fall within one or more of the categories

What is the policy for 2020 UDI Compliance Policy Guidance?

85 FR 39477

What is a biological product regulated under section 351 of the Public Health Service Act?

a drug or a device

What is the name of the agency that determines that class I devices are not considered consumer health products?

FDA

What are er risk devices subject to?

additional regulatory controls

What is the majority of class I devices exempt from?

the 510(k) premarket notification process

What is a clinical labora?

a clinical labora

What is the name of the subpart B of 21 CFR 801.40?

21 CFR 801.40

What is the name of the UDI that a user can use in addition to a UPC?

UDI

What is the definition of a prescription use?

prescription use

What is a life-supporting or life-sustaining device defined at 21 CFR 860.3 as?

a device that is “essential to, or that yie Answer: Life-supporting or life-sustaining device”

What does FDA recommend evaluating to determine if a particular device is life-supporting or life-sustaining?

the device’s intended use

What is the purpose of reusable vices?

intended for use by healthcare professionals only

What is the PFS for the PFS, elastomeric plunger, and needle?

the PFS

What is the term for a device that is intended to be used more than once on or by the same patient?

reusable

What does an unclassified device generally require?

submission of a 510(k) premarket notification

How many calendar days are required to submit a GUDID submission under 21 CFR 830.300 for unclassified devices?

75 calendar days

What is the direct mark compliance date for LS/LS devices?

September 24, 2015

What is the purpose of this provision?

reduce burden associated with the UDI Rule for inventories of finished devices that were manufactured and labeled prior to the applicable compliance date

What is the name of the guidance that describes the intention to exempt certain Unclassified Medical Devices from Premarket Notification Requirements?

“Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements”

What does the UDI Compliance Policy Guidance state that we do not intend to enforce the GUDID data submission requirements for?

unclassified devices

What is the name of the document that may be applicable to UDI?

tem/udi-exceptions-alternatives- and-time-extensions

What do labelers use the new field(s) to document when the field becomes available?

that their devices are subject to such a method

What is the ompliance date for class I and unclassified devices?

September 24, 2020

What is the step of the applicant that considers whether other existing information may be leveraged to 295 support the items in Step 4?

Step 4

What is the ark requirements under 21 CFR 801.45 for?

finished class I and unclassified devices

What is FDA looking for in a method for constructing the UDI?

documented or referenced that method in the DMR

What is the policy for UDI direct mark requirements under 21 CFR 801.45 for class I and unclassified devices, other than LS/LS devices, remains the same as the policy in the 2020 UDI Compliance Policy Guidance.?

null

What is the name of the FDA's Office of the Commissioner?

Office of the Commissioner

What is the name of the office of Communication, Education, and Radiation Programs Division of Small Manufacturers, International, and Consumer Assistance Center for Devices and Radiological Health?

Office of Communication, Education, and Radiation Programs

What is the name of the veterinary clinic in the US?

HFV-12

What is the name of the system that stores data?

Retrieving Data 6

What does not create or confer any rights for or on any person and does not operate to bind FDA or the public.?

null

What is the name of the FDA staff that implements this guidance?

FDA staff

What is the applicant considering establishing between the previously approved 302 product and the proposed autoinjector?

a bridge

What is the source data needed for?

the reconstruction and evaluation of the study to determine the safety of food and color additives and safety and effectiveness of new human and animal drugs,3 and medical devices

What is the name of the guidance that was issued in April 1999?

Electronic Records; Electronic Signatures — Scope and Application

What does the Agency intend to do with part 11?

interpret the scope of part 11 narrowly and to exercise enforcement discretion with regard to part 11 requirements for validation, audit trails, record retention, and record copying

What does the word should mean in Agency guidances?

something is suggested or recommended, but not required

What must be the same fundamental elements of data quality as paper records?

attributable, legible, contemporaneous, original,5 and accurate

What did FDA say was acceptable under certain circumstances?

electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records and handwritten signatures executed on paper

What was the final draft guidance for industry entitled?

Computerized Systems Used in Clinical Trials

What is allowing original documents to be replaced by copies?

copies

What does this guidance apply to computerized systems that capture analytical results of tests conducted during a clinical trial?

21 CFR 312.62(b) and 812.140(b)

What is an example of a computerized system that can be used to record an ECG reading?

an ECG reading

What is the purpose of the HF validation study?

it will be challenging to bridge the applications

What is IDE?

Investigational Device Exemption

What should the computerized systems do?

(1) to prevent errors in data creation, modification, maintenance, archiving, retrieval, or transmission

What should be maintained either on-site or be remotely accessible through electronic files as part of the specific study records?

SOPs

What is the source document when original observations are entered directly into a computerized system?

the electronic record

What is the name of the system that a data is entered directly into a remote computerized system?

a remote computerized system

What must be limited to authorized individuals?

Limited Access Access

What should individuals work only under?

their own password or other access key and not share these with others

What should someone do when they leave a workstation?

log off the system

What does the use of audit trails help to ensure?

only authorized additions, deletions, or alterations of information in the electronic record have occurred

What should be determined based on a justified and documented risk assessment?

The need for audit trails

What did the applicant believe it could leverage because of the previously approved autoinjector design?

design verification data unrelated to the drug being injected

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

Audit trails or other security methods

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

authorized personnel

What do systems recommend that dates and times include?

year, month, day, hour, and minute

What is better for systems that span different time zones?

time stamps

What should be put in place to prevent the altering, browsing, querying, or reporting of data via external software applications that do not enter through the protective system software.?

null

What should be kept in the study documentation?

that record

What can be used to permit repopulation of information specific to the subject?

programming features

What should be designed in a way that retrieved data regarding each individual subject in a study is attributable to that subject?

computerized system

What is not necessary to reprocess data from a study that can be fully reconstructed from available documentation?

actual application software, operating systems, and software development tools

What should be designed to protect against data loss?

sufficient backup and recovery procedures

What is the applicant planning to provide design validation confirming?

that the autoinjector 323 performance specifications are adequate

Where should records be stored?

at a secure location

What should be documented for changes that exceed previously established operational limits or design specifications?

Changes that exceed previously established operational limits or design specifications

What should be provided to individuals in the specific operations with regard to computerized systems that they are to perform?

Training

What is a process that captures details such as additions, deletions, or alterations of information in an electronic record?

Audit Trail

What is an example of a computerized system?

user manual

What is an electronic record?

any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained

What is allowing original documents and the original data recorded on those documents to be replaced by copies?

copies

What is the purpose of a Transmit?

to transfer data within or Answer: Answer: at the pharmacy, at the laboratories, and at medico-technical departments involved in a clinical trial

What is the name of the guideline for the Monitoring of Clinical Investigations?

Guideline for the Monitoring of Clinical Investigations

What should the SOPs include?

System setup/installation

What is the OEB?

lung computed tomography system, computer-aided detection

What is the name of the document that contains nonbinding recommendations Draft—Not for Implementation?

21 CFR 820.30(g) & (j)

What is the name of the system maintenance?

System decommissioning

What is the name of the agency that oversees the use of computerized systems in clinical trials?

Office of the Commissioner

What is the phone number for the Drug Information Center for Drug Evaluation and Research?

301-827-4573

What is the name of the veterinary center that is located in the US?

HFV-12 Center for Veterinary Medicine

What is the name of the office that oversees the Food and Drug Administration?

Office of the Commissioner

What does the guidance represent?

the Food and Drug Administration's (FDA's) current thinking on this topic

What is the FDA's staff responsible for implementing?

this guidance

What are CROs?

data management centers

What is the name of the guidance dated April 1999?

Part 11

What is the purpose of the local adverse event data?

assess how the new interface may affect pain on delivery

What is the ICH E6 Good Clinical Practice consol?

Answer: Answer: ICH E6 Good Clinical Practice consol

What are the terms used in FDA guidance to describe the same information?

source documents

What does ICH stand for?

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use

What is an increasing use of computerized systems in clinical trials to generate and maintain source data and source documentation on each clinical trial subject?

computerized systems

What is the requirement for FDA's acceptance of data from clinical trials for decision-making purposes?

FDA's ability to verify the quality and integrity of the data during FDA on-site inspections and audits

What did FDA and industry want to do with part 11?

proposeing additional rulemaking, and exercising enforcement discretion regarding enforcement of certain part 11 requirements

What is the final version of the draft guidance for industry entitled Electronic Records; Electronic Signatures – Scope and Application (Scope and Application Guidance) dated August 2003.?

null

What is the approach outlined in the Scope and Application Guidance?

The approach outlined in the Scope and Application Guidance