Funybubble/fda · Datasets at Hugging Face

Question stringlengths 13 1.05k ⌀	Answer stringlengths 2 801 ⌀
What was the PMA applicant's original use?	HIV diagnostic
What did the actual analyte do?	did not
What is the CDRH's focus?	the cause or progression of the neurological disorder or condition
What was the PMA applicant modified to include?	the mitral position
What can physiological and potential performance differences between the two positions significantly impact?	clinical outcome
What was not needed because the test data provided in the original PMA were sufficient to support the valve for use in the mitral position.?	null
What is required for certain types of significant changes to the approved device that affect safety or effectiveness of the device?	Submission of a 180-day supplement
What is needed to demonstrate reasonable assurance of safety and effectiveness of the modified device?	new preclinical testing
What is the most common type of clinical data that FDA believes is appropriate for a 180-day supplement?	a limited number of patients, shorter study duration, and/or a subset of endpoints
What is the name of the change FDA approved for a device modification?	C1. Design Change
What is a VAD intended for?	temporary mechanical circulatory support for patients awaiting a cardiac transplant
What was the deadline for the submission of the 180-day supplement?	180-day supplement
What did FDA determine was adequate to demonstrate reasonable assurance of the safety and effective?	preclinical testing
What is the purpose of this guidance?	We recommend that you use this document to help determine the types of data that may be needed to support an IDE application and to help in the design of clinical trials.
What did the PMA applicant add to the chemical formulation of the lens?	ultraviolet (UV) light blocking material
What was the reason FDA determined that the submission of a 180-day supplement was appropriate for this change?	to demonstrate a reasonable assurance of the safety and effectiveness of this modification
What was needed to demonstrate that the modified device met the specifications of the original device?	comparative bench testing
What was the name of the new automated analyzer used in the PMA?	OIVD
What was appropriate for this change?	a submission of a 180-day supplement
What impacted the electrical characteristics of the device?	These changes impacted the electrical characteristics of the device
What did FDA approve for an endovascular stent graft system?	PMA
What was the new graft woven into?	a denser weave configuration
What was the submission of a 180-day supplement appropriate for?	this change
What was needed to assess the performance of the modified device?	verification and validation testing
What is the name of the CADe device that is not subject to the guidance?	non-CADe devices
What does the word should mean in Agency guidance?	something is suggested or recommended, but not required
What was FDA's PMA for?	pneumatic ventricular assist device (VAD)
What was the PMA applicant's primary concern?	heart failure awaiting a cardiac transplant
What was sufficient to demonstrate reasonable assurance of safety and effectiveness of the modified device?	new bench testing and the limited confirmatory clinical study
What was the purpose of the PMA?	HIV diagnostic intended for fingerstick, whole blood specimens
What was the FDA's recommendation for a 180-day supplement?	The clinical data necessary to support the modification was limited
What is the name of the document that provides information about the process for the real-time review program?	Real-Time Premarket Approval Application (PMA) Supplements
What is the FDA not aware of when a real-time PMA supplement would be appropriate for changes that affect an indication for use?	a situation in which a real-time PMA supplement would be appropriate
What was the test method previously accepted by FDA?	test method
What was the ientific discipline of electrical engineering?	electrical engineering
What was the upper limit for the storage temperature for bone graft?	25°C
What is the purpose of clinical trials that investigate neurological devices using biological markers and clinical outcome assessments?	general study design considerations
What was the new higher temperature sufficient to support the change?	Stability data
What was performed to evaluate the physical, chemical, and biological stability of the device during storage?	Accelerated and long-term testing
What was the PMA applicant proposing to modify?	excimer laser system
What scientific discipline was sufficient to support this minor change?	electrical engineering
What did the FDA approve for its alternate wet shipping solution?	o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o: PMA applicant proposed to use an alternate wet shipping solution for its permeable extended wear contact lenses.
What was the concern with the new solution?	compatibility with the contact lens
What was the single scientific discipline of?	mechanical engineering
What does 21 CFR 814.39(d)(1) and (d)(2) provide?	certain labeling and manufacturing changes that enhance the safety of the device or the safety in the use of the device may be submitted as a supplement marked “Special PMA Supplement – Changes Being Effected.”
What is a condition of prior FDA approval?	lawful distribution
What does the FDA allow for safety-related warnings for which there is reasonable evidence of a causal association?	safety-related warnings
What is an intermediate endpoint?	a clinical endpoint concerning a symptom or measure of function that is not the ultimate outcome of the disease
What is the final rule published by FDA?	Supplemental Applications Proposing Labeling Changes for Approved Drugs, Biologics, and Medical Devices
What does the limited Special PMA Supplement possesses when it possesses new information that provides a scientifically legitimate foundation for modifying the FDA-approved labeling?	the applicant may place the change in effec
What does the PMA supplement provide about the basis for the changes?	full explanation
What should be considered temporary while FDA reviews the supplement?	how the change enhances the safety of the device or the safety in the use of the device
What is the regulation allowing both labeling and manufacturing changes that enhance the safety of the device?	21 CFR 814.39(d)(2)
What is the most common reason for a manufacturing change to be reviewed as a Special PMA Supplement?	to enhance safety but not to impact effectiveness
What is the most appropriate type of supplement if the quality control or manufacturing process change impacts the device specifications and/or performance of the device. Special PMA Supplement?	null
What was the reason for a Special PMA Supplement?	Because this modification to the warning of the labeling enhanced safety with no impact on effectiveness
What did the PMA applicant add to the manufacturing process to help with the source wire component of its intravascular brachytherapy system?	a secondary wipe station
What was the PMA applicant's reason for making the urethral stent labeled change?	enhanced safety with no impact on effectiveness
What is an intermediate endpoint used as a substitute for?	a clinical endpoint
What did the manufacturing process of a duett sealing device ensure?	a tight fit between the two mating parts
What was the source of the error message?	A greater than normal air gap between two inductors on one of the circuit boards
What is the name of the Act that allows a PMA applicant to submit written notification to the agency of a modification to the manufacturing procedure or method of manufacture affecting the safety and effectiveness?	FDAMA
How long may the applicant distribute the device after the date on which FDA receives the notice?	30 days
What is the name of the guidance document that contains Nonbinding Recommendations?	30-Day Notices and 135-Day PMA Supplements for Manufacturing Method or Process Changes
What is the PMA applicant's manufacturing process for a cardiac resynchronization therapy pacemaker called?	CRT-P
What was the PMA applicant's qualified supplier for the manufacture of a critical component used in the calibrator of its Hepatitis B surface antigen assay?	OIVD
What is PMMA used for?	manufacture of a single-piece intra-ocular lens
What was the 30-day notice converted to?	135-day supplement
What did the PMA applicant make a change that included moving the in- process quality control monitoring step for endotoxin to a different location in the process flow?	The PMA applicant provided adequate documentation in the 30-day notice to support this change in the manufacturing process of the prosthesis
What is sometimes used as endpoints in trials of antihypertensive therapeutics?	blood pressure measurements
What was the 30-day notice converted to?	a 135-day supplement
What was the time period in which the PMA applicant submitted a change to incorporate an alternate backup deployment test methodology in its manufacturing process?	135-day supplement
What is the term for release based on demonstrating no growth of biological indicators?	n parameters
What are the 180-day supplements called?	Manufacturing site change supplements
What describes the criteria for manufacturing site change supplements and when an inspection would likely occur?	CDRH intends to issue a separate guidance document
What is the expectation for a manufacturing site change supplement?	for a manufacturing site
What is required of a PMA applicant after approval?	to submit reports to FDA annually
What is the term used to refer to periodic reports by FDA and industry as?	periodic reports
What does not need to be reported in the annual report because the Agency did not believe that these impact safety or effectiveness?	changes
What does not impact the safety and effectiveness of the device?	Reducing a maximum temperature specification
What are some examples of neurological diseases?	Alzheimer’s disease, Parkinson’s Disease, or Primary Dystonia
What was the restricted range optimal for?	low processing times and high yields
What is the tolerance limit?	0.4°C
What did the olerance limits provide?	additional assurance of device quality
What was previously validated and incorporated in the pump manufacturing process?	non-automated test
What is a minor change to the device, Changes in labeling, Changes to a The use of a different in design or components, materials, such as a minor change to the quality control, or manufacturing facility or performance of the design, specification, design of the device, software, manufacturing processes procedure or establishment to device, or a new software, color additives, sterilization, or labeling?	null
What is the MDTCA?	Public Law 108-214)
What is the main reason for a change in labeling?	to strengthen, or delete effectiveness
What is the additional assurance of clinical data to support?	FDA-accepted test method, purity, identity, strength, the change
What is the main purpose of the modification?	Identify the modification and reason for it
What may or may not agree with your asses?	Changes Being Effected A FDA may or may not agree with your asses
What is the reason for patients forgo currently approved treatments in earlier stages of disease?	patients forgo currently approved treatments
What is the name of the person who can be contacted for questions regarding the OIVD document?	Kyle J. Myers
What is the name of the division that handles dockets?	Food and Drug Administration
Where can you obtain a hard copy of the guidance?	301-847-8149
What is the name of the Detector?	Flat Field Correction
What is the name of the system that generates X-rays?	X-ray Generator
What is the name of the ELECTRICAL SAFETY?	6 6.
What is the name of the device that is being tested?	PHANTOM TESTING
What is class II of full-field digital mammographic devices?	special controls

What was the PMA applicant's original use?

HIV diagnostic

What did the actual analyte do?

did not

What is the CDRH's focus?

the cause or progression of the neurological disorder or condition

What was the PMA applicant modified to include?

the mitral position

What can physiological and potential performance differences between the two positions significantly impact?

clinical outcome

What was not needed because the test data provided in the original PMA were sufficient to support the valve for use in the mitral position.?

null

What is required for certain types of significant changes to the approved device that affect safety or effectiveness of the device?

Submission of a 180-day supplement

What is needed to demonstrate reasonable assurance of safety and effectiveness of the modified device?

new preclinical testing

What is the most common type of clinical data that FDA believes is appropriate for a 180-day supplement?

a limited number of patients, shorter study duration, and/or a subset of endpoints

What is the name of the change FDA approved for a device modification?

C1. Design Change

What is a VAD intended for?

temporary mechanical circulatory support for patients awaiting a cardiac transplant

What was the deadline for the submission of the 180-day supplement?

180-day supplement

What did FDA determine was adequate to demonstrate reasonable assurance of the safety and effective?

preclinical testing

What is the purpose of this guidance?

We recommend that you use this document to help determine the types of data that may be needed to support an IDE application and to help in the design of clinical trials.

What did the PMA applicant add to the chemical formulation of the lens?

ultraviolet (UV) light blocking material

What was the reason FDA determined that the submission of a 180-day supplement was appropriate for this change?

to demonstrate a reasonable assurance of the safety and effectiveness of this modification

What was needed to demonstrate that the modified device met the specifications of the original device?

comparative bench testing

What was the name of the new automated analyzer used in the PMA?

OIVD

What was appropriate for this change?

a submission of a 180-day supplement

What impacted the electrical characteristics of the device?

These changes impacted the electrical characteristics of the device

What did FDA approve for an endovascular stent graft system?

PMA

What was the new graft woven into?

a denser weave configuration

What was the submission of a 180-day supplement appropriate for?

this change

What was needed to assess the performance of the modified device?

verification and validation testing

What is the name of the CADe device that is not subject to the guidance?

non-CADe devices

What does the word should mean in Agency guidance?

something is suggested or recommended, but not required

What was FDA's PMA for?

pneumatic ventricular assist device (VAD)

What was the PMA applicant's primary concern?

heart failure awaiting a cardiac transplant

What was sufficient to demonstrate reasonable assurance of safety and effectiveness of the modified device?

new bench testing and the limited confirmatory clinical study

What was the purpose of the PMA?

HIV diagnostic intended for fingerstick, whole blood specimens

What was the FDA's recommendation for a 180-day supplement?

The clinical data necessary to support the modification was limited

What is the name of the document that provides information about the process for the real-time review program?

Real-Time Premarket Approval Application (PMA) Supplements

What is the FDA not aware of when a real-time PMA supplement would be appropriate for changes that affect an indication for use?

a situation in which a real-time PMA supplement would be appropriate

What was the test method previously accepted by FDA?

test method

What was the ientific discipline of electrical engineering?

electrical engineering

What was the upper limit for the storage temperature for bone graft?

25°C

What is the purpose of clinical trials that investigate neurological devices using biological markers and clinical outcome assessments?

general study design considerations

What was the new higher temperature sufficient to support the change?

Stability data

What was performed to evaluate the physical, chemical, and biological stability of the device during storage?

Accelerated and long-term testing

What was the PMA applicant proposing to modify?

excimer laser system

What scientific discipline was sufficient to support this minor change?

electrical engineering

What did the FDA approve for its alternate wet shipping solution?

o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o Answer: o: PMA applicant proposed to use an alternate wet shipping solution for its permeable extended wear contact lenses.

What was the concern with the new solution?

compatibility with the contact lens

What was the single scientific discipline of?

mechanical engineering

What does 21 CFR 814.39(d)(1) and (d)(2) provide?

certain labeling and manufacturing changes that enhance the safety of the device or the safety in the use of the device may be submitted as a supplement marked “Special PMA Supplement – Changes Being Effected.”

What is a condition of prior FDA approval?

lawful distribution

What does the FDA allow for safety-related warnings for which there is reasonable evidence of a causal association?

safety-related warnings

What is an intermediate endpoint?

a clinical endpoint concerning a symptom or measure of function that is not the ultimate outcome of the disease

What is the final rule published by FDA?

Supplemental Applications Proposing Labeling Changes for Approved Drugs, Biologics, and Medical Devices

What does the limited Special PMA Supplement possesses when it possesses new information that provides a scientifically legitimate foundation for modifying the FDA-approved labeling?

the applicant may place the change in effec

What does the PMA supplement provide about the basis for the changes?

full explanation

What should be considered temporary while FDA reviews the supplement?

how the change enhances the safety of the device or the safety in the use of the device

What is the regulation allowing both labeling and manufacturing changes that enhance the safety of the device?

21 CFR 814.39(d)(2)

What is the most common reason for a manufacturing change to be reviewed as a Special PMA Supplement?

to enhance safety but not to impact effectiveness

What is the most appropriate type of supplement if the quality control or manufacturing process change impacts the device specifications and/or performance of the device. Special PMA Supplement?

null

What was the reason for a Special PMA Supplement?

Because this modification to the warning of the labeling enhanced safety with no impact on effectiveness

What did the PMA applicant add to the manufacturing process to help with the source wire component of its intravascular brachytherapy system?

a secondary wipe station

What was the PMA applicant's reason for making the urethral stent labeled change?

enhanced safety with no impact on effectiveness

What is an intermediate endpoint used as a substitute for?

a clinical endpoint

What did the manufacturing process of a duett sealing device ensure?

a tight fit between the two mating parts

What was the source of the error message?

A greater than normal air gap between two inductors on one of the circuit boards

What is the name of the Act that allows a PMA applicant to submit written notification to the agency of a modification to the manufacturing procedure or method of manufacture affecting the safety and effectiveness?

FDAMA

How long may the applicant distribute the device after the date on which FDA receives the notice?

30 days

What is the name of the guidance document that contains Nonbinding Recommendations?

30-Day Notices and 135-Day PMA Supplements for Manufacturing Method or Process Changes

What is the PMA applicant's manufacturing process for a cardiac resynchronization therapy pacemaker called?

CRT-P

What was the PMA applicant's qualified supplier for the manufacture of a critical component used in the calibrator of its Hepatitis B surface antigen assay?

OIVD

What is PMMA used for?

manufacture of a single-piece intra-ocular lens

What was the 30-day notice converted to?

135-day supplement

What did the PMA applicant make a change that included moving the in- process quality control monitoring step for endotoxin to a different location in the process flow?

The PMA applicant provided adequate documentation in the 30-day notice to support this change in the manufacturing process of the prosthesis

What is sometimes used as endpoints in trials of antihypertensive therapeutics?

blood pressure measurements

What was the 30-day notice converted to?

a 135-day supplement

What was the time period in which the PMA applicant submitted a change to incorporate an alternate backup deployment test methodology in its manufacturing process?

135-day supplement

What is the term for release based on demonstrating no growth of biological indicators?

n parameters

What are the 180-day supplements called?

Manufacturing site change supplements

What describes the criteria for manufacturing site change supplements and when an inspection would likely occur?

CDRH intends to issue a separate guidance document

What is the expectation for a manufacturing site change supplement?

for a manufacturing site

What is required of a PMA applicant after approval?

to submit reports to FDA annually

What is the term used to refer to periodic reports by FDA and industry as?

periodic reports

What does not need to be reported in the annual report because the Agency did not believe that these impact safety or effectiveness?

changes

What does not impact the safety and effectiveness of the device?

Reducing a maximum temperature specification

What are some examples of neurological diseases?

Alzheimer’s disease, Parkinson’s Disease, or Primary Dystonia

What was the restricted range optimal for?

low processing times and high yields

What is the tolerance limit?

0.4°C

What did the olerance limits provide?

additional assurance of device quality

What was previously validated and incorporated in the pump manufacturing process?

non-automated test

What is a minor change to the device, Changes in labeling, Changes to a The use of a different in design or components, materials, such as a minor change to the quality control, or manufacturing facility or performance of the design, specification, design of the device, software, manufacturing processes procedure or establishment to device, or a new software, color additives, sterilization, or labeling?

null

What is the MDTCA?

Public Law 108-214)

What is the main reason for a change in labeling?

to strengthen, or delete effectiveness

What is the additional assurance of clinical data to support?

FDA-accepted test method, purity, identity, strength, the change

What is the main purpose of the modification?

Identify the modification and reason for it

What may or may not agree with your asses?

Changes Being Effected A FDA may or may not agree with your asses

What is the reason for patients forgo currently approved treatments in earlier stages of disease?

patients forgo currently approved treatments

What is the name of the person who can be contacted for questions regarding the OIVD document?

Kyle J. Myers

What is the name of the division that handles dockets?

Food and Drug Administration

Where can you obtain a hard copy of the guidance?

301-847-8149

What is the name of the Detector?

Flat Field Correction

What is the name of the system that generates X-rays?

X-ray Generator

What is the name of the ELECTRICAL SAFETY?

6 6.

What is the name of the device that is being tested?

PHANTOM TESTING

What is class II of full-field digital mammographic devices?

special controls