Funybubble/fda · Datasets at Hugging Face

Question stringlengths 13 1.05k ⌀	Answer stringlengths 2 801 ⌀
What does the applicant determine is the same with Combination Product A?	the materials remain the same
What should an RFD say about a wound dressing?	the dressing should be used over a four-hour period
How many days does a period of time not to exceed?	10 days
What would you identify in a combination product wound dressing?	the specific amount of the drug contained in the device, and that it would be applied topically to the specific type of wound your product is intended to treat
What should you describe if your product is an injectable product?	the amount of product being injected and the site of the injection
What is the product application number?	510(k) or NDA number
What is often helpful in describing the product, its components, and its modes of action?	literature references
What should your classification recommendation be based on?	composition, mode(s) of action, and intended use(s) of your product
What should you state if you believe your product is a combination product?	what type of combination product it may be (e.g., drug/device) and your rationale for this recommendation
What is the algorithm used to make a recommendation of a lead center?	21 CFR 3.4(b)
What is the most important section of an RFD summarized in?	Section IV
When is the premarket notification issued?	January 22, 2020
What is the 21 CFR classification of computer-assisted acquisition/optimization devices?	892.21
What is the intended patient population for Combination Product A?	change in drug
What do you think your product should be classified and assigned?	how do you think your product should be classified and assigned, and why
What is the name of the sponsor?	The identity of the sponsors, and the status of any discussions or agreements between the sponsors regarding the use of this product as a component of a new combination product
What is the description of the manufacturing processes?	Description of all known modes of action
What must the sponsor's recommendation be based on?	assignment algorithm
What is the name of the document that supersedes the document that supersedes the document that supersedes the document that supersedes the document that supersedes the document that supersedes the document that supersedes the document that supersedes the document that supersedes the document that supersedes the document that supersedes the document that supersedes the document that supersedes the document that supersedes the document that supersedes the document in the review of PM Answer: PM Answer: PM Answer: PM Answer: PM Answer: PM Answer: PM Answer: PM Answer: most expertise related to the most significant safety and effectiveness questions 1 7 Guidance for Industry and FDA Staff Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process?	null
What is the name of the office that handles the application of this guidance to devices regulated by the Center for Biologics Evaluation and Research?	Office of Communication, Training and Manufacturers’ As Answer: Nicole L. Wolanski
What is the name of the division that the Food and Drug Administration has in charge of dockets management?	Division of Dockets Management, Food and Drug Administration
What is the name of the center that provides guidance on radiological health?	Center for Devices and Radiological Health
Where is the document number for this document?	Office of Communication, Training and Manufacturers Assistance (HFM-40)
What is the least Burdensome Approach?	PMA Supplement
What is the purpose of the HF validation study report?	produce a HF validation study report
What is OIVD?	Significant Modification of Technology
What is the change in Indication for Use - Different Surgical Procedure 10 B6.?	null
What is the name of the new device Feature?	CBER
What is the name of the alternative supplier of critical component?	OIVD
What is the name of the Guidance for Industry and FDA Staff Modifications to Devices Subject to Premarket Approval?	Guidance for Industry and FDA Staff
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 purpose of this guidance document?	to establish a clear and consistent way to approach the decision-making process you follow to determine the type of regulatory submission, if any, that may be required when you modify your lawfully marketed PMA device
What is the section 515 of the Federal Food, Drug, and Cosmetic Act?	section 515
What does the guidance provide examples of?	various types of device modifications
What is the purpose of modifying a PMA device in response to a recall?	to assure the continued safety and/or effectiveness of the device
What is the name of the division that evaluates neurostimul?	Neurological and Physical Medicine Devices Neurostimul
What does the word should mean in Agency guidance documents?	something is suggested or recommended, but not required
What does this guidance reflect?	our careful review of the relevant scientific and legal requirements
What is the term used to describe the requirements for periodic reporting?	continuing evaluation
When was the draft version of this guidance document issued?	March 9, 2007
What was the response of industry to the August 1998 draft guidance?	FDA’s response
What was the MDUFMA's name?	Medical Device User Fee and Modernization Act of 2002
What did Industry request?	a detailed flowchart
What did FDA provide where possible?	additional clarity for some terminology
Why has FDA chosen not to include 30-day supplements within the scope of the guidance document?	because we have not identified cases for which this provision can be effectively applied
What is the general requirement for when a PMA supplement is needed?	21 CFR 814.39(a)
What is the name of the branch that handles electronic comments?	Devices Branch
What is the use of a different facility or establishment to manufacture, process, or package the device?	manufacture, process, or package the device
What is the name of the periodic report that reports a change to a manufacturing procedure or method of manufacture that has been approved by FDA?	21 CFR 814.39(b)
What does the QS regulation require of you?	have in place a system to document and assess design changes
What is the primary indicator of what type of PMA submission is needed?	the nature of the data, if any, that is needed to demonstrate the safety and effectiveness of the modified device
What do we believe are needed to support the safety and effectiveness of such changes?	general nature of test data
What is the OIVD?	Safety
What is the purpose of the examples in this document?	to demonstrate the underlying principles
What is the term for in vitro diagnostics?	IDDs
What should you do when deciding whether to submit a supplement to your approved traditional PMA or to submit a new traditional PMA5 for a modified device?	ascertain whether, and to what extent, you can rely on the preclinical testing and clinical data submitted in your traditional PMA to support the safety and effectiveness of your modified device.
What does each example describe?	a device revie
What is the name of the Biological Markers and Clinical Endpoints?	6 1. Biomarker Tests
What is the procedure where the chest is opened by surgical incision?	TransMyocardial Revascularization (TMR) holmium laser
What is the laser penetrating entirely through the wall into the ventricular cavity?	hole
What is the term used to describe a study using a patient population with a defined clinical condition to determine the safety and effectiveness of the device?	clinical data
What is the PMA that is used in place of a traditional PMA?	modular PMA
What is PMR?	a non-surgical procedure
What was needed to assess the impact of the change in the device?	new preclinical testing
What was the purpose of the PMA?	Because new preclinical and clinical data were necessary to demonstrate a reasonable assurance of safety and effectiveness for the modification
What did the PMA applicant modify the lead by adding a steroid eluting piece to the distal lead tip to reduce?	the inflammatory process
What did the modified lead design raise questions about?	longer battery life and lower stimulation threshold
What was needed to demonstrate that the steroid-eluting lead remained as safe and effective as the approved non-steroid lead?	New preclinical and clinical data
What is IDEs?	Neurological Devices Targeting Disease Progression and Clinical Outcomes
What was the PMA meant to detect?	total prostate-specific antigen (total PSA) in serum
What were the analytical performance characteristics of the two assays?	differ
What is the OIVD?	Significant Modification of Technology
What is the name of the membrane-bound EIA?	membrane-bound EIA
What is the term for a panel-track supplement?	d
What is the MDTCA?	Medical Devices Technical Corrections Act
What describes when a Panel meeting may be held?	21 CFR 814.44
What is the term for a new clinical data set that is intended to provide valid scientific evidence necessary to support the safety and effectiveness of the modified device?	substantial clinical data
What is a nonbinding recommendation about the intended patient population?	null
What would generally require significant labeling changes?	Changes in these clinical aspects
What is the most appropriate supplement type for a change in indication for use or a change to (or removal of) a contraindication of the device?	panel-track supplement
What does novel treatments revolutionize?	how neurological diseases or conditions are treated
What is the FDA's view of a change in indication?	indication or contraindication changes generally do not require or require very limited new preclinical testing
What was the VAD indicated for?	temporary, mechanical circulatory support of nonreversible left ventricular failure in patients awaiting cardiac transplant
What are the two patient populations?	destination therapy patients are precluded from a transplant because they do not meet the age requirement or they have one or more co-morbid conditions (e.g., diabetes).
What was needed to demonstrate reasonable assurance of safety and effectiveness for longer term implantation?	New clinical data
What was the original PMA tested for?	safety and effectiveness
What was needed to support the safety and effectiveness of the device?	new clinical data
What was the original indication for urethral strictures?	the device is inserted into the bulbar urethra in order to improve urine flow and prevent recurrence of strictures
What is the new target patient population's risk related to?	age, overall health and anatomical location where the device is to be used
What is the risk of adverse tissue response due to the presence of the stent in hyperplastic tissue?	presence of the stent in hyperplastic tissue
What was the PMA approved for?	high frequency oscillatory ventilator
What is the FDA's role in the clinical trials of medical devices targeting neurological disease progression?	conduct clinical trials
What was the new indication for adults with adult respiratory distress syndrome?	adults with adult respiratory distress syndrome
What was needed to evaluate the safety and effectiveness of the device in the new population?	new clinical data
What did the PMA applicant modify to add pediatric patients?	the indication for use
What was the purpose of the new clinical testing?	to demonstrate that the device provided reasonable assurance of safety and effectiveness for the new pediatric patient population
What is nearsightedness?	myopia
What were concerns associated with the intrastomal ablation used in the new indication?	new risks and clinical effectiveness concerns
What was the PMA approved for?	a soft silicone hydrogel extended wear (1 to 7 days) contact lens indicated for the correction of myopia or hyperopia
What was the new safety concerns raised by the extended time of wear?	increased risk of ocular adverse events, such as corneal microbial keratitis, and corneal infiltrated lesions

What does the applicant determine is the same with Combination Product A?

the materials remain the same

What should an RFD say about a wound dressing?

the dressing should be used over a four-hour period

How many days does a period of time not to exceed?

10 days

What would you identify in a combination product wound dressing?

the specific amount of the drug contained in the device, and that it would be applied topically to the specific type of wound your product is intended to treat

What should you describe if your product is an injectable product?

the amount of product being injected and the site of the injection

What is the product application number?

510(k) or NDA number

What is often helpful in describing the product, its components, and its modes of action?

literature references

What should your classification recommendation be based on?

composition, mode(s) of action, and intended use(s) of your product

What should you state if you believe your product is a combination product?

what type of combination product it may be (e.g., drug/device) and your rationale for this recommendation

What is the algorithm used to make a recommendation of a lead center?

21 CFR 3.4(b)

What is the most important section of an RFD summarized in?

Section IV

When is the premarket notification issued?

January 22, 2020

What is the 21 CFR classification of computer-assisted acquisition/optimization devices?

892.21

What is the intended patient population for Combination Product A?

change in drug

What do you think your product should be classified and assigned?

how do you think your product should be classified and assigned, and why

What is the name of the sponsor?

The identity of the sponsors, and the status of any discussions or agreements between the sponsors regarding the use of this product as a component of a new combination product

What is the description of the manufacturing processes?

Description of all known modes of action

What must the sponsor's recommendation be based on?

assignment algorithm

What is the name of the document that supersedes the document that supersedes the document that supersedes the document that supersedes the document that supersedes the document that supersedes the document that supersedes the document that supersedes the document that supersedes the document that supersedes the document that supersedes the document that supersedes the document that supersedes the document that supersedes the document that supersedes the document in the review of PM Answer: PM Answer: PM Answer: PM Answer: PM Answer: PM Answer: PM Answer: PM Answer: most expertise related to the most significant safety and effectiveness questions 1 7 Guidance for Industry and FDA Staff Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process?

null

What is the name of the office that handles the application of this guidance to devices regulated by the Center for Biologics Evaluation and Research?

Office of Communication, Training and Manufacturers’ As Answer: Nicole L. Wolanski

What is the name of the division that the Food and Drug Administration has in charge of dockets management?

Division of Dockets Management, Food and Drug Administration

What is the name of the center that provides guidance on radiological health?

Center for Devices and Radiological Health

Where is the document number for this document?

Office of Communication, Training and Manufacturers Assistance (HFM-40)

What is the least Burdensome Approach?

PMA Supplement

What is the purpose of the HF validation study report?

produce a HF validation study report

What is OIVD?

Significant Modification of Technology

What is the change in Indication for Use - Different Surgical Procedure 10 B6.?

null

What is the name of the new device Feature?

CBER

What is the name of the alternative supplier of critical component?

OIVD

What is the name of the Guidance for Industry and FDA Staff Modifications to Devices Subject to Premarket Approval?

Guidance for Industry and FDA Staff

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 purpose of this guidance document?

to establish a clear and consistent way to approach the decision-making process you follow to determine the type of regulatory submission, if any, that may be required when you modify your lawfully marketed PMA device

What is the section 515 of the Federal Food, Drug, and Cosmetic Act?

section 515

What does the guidance provide examples of?

various types of device modifications

What is the purpose of modifying a PMA device in response to a recall?

to assure the continued safety and/or effectiveness of the device

What is the name of the division that evaluates neurostimul?

Neurological and Physical Medicine Devices Neurostimul

What does the word should mean in Agency guidance documents?

something is suggested or recommended, but not required

What does this guidance reflect?

our careful review of the relevant scientific and legal requirements

What is the term used to describe the requirements for periodic reporting?

continuing evaluation

When was the draft version of this guidance document issued?

March 9, 2007

What was the response of industry to the August 1998 draft guidance?

FDA’s response

What was the MDUFMA's name?

Medical Device User Fee and Modernization Act of 2002

What did Industry request?

a detailed flowchart

What did FDA provide where possible?

additional clarity for some terminology

Why has FDA chosen not to include 30-day supplements within the scope of the guidance document?

because we have not identified cases for which this provision can be effectively applied

What is the general requirement for when a PMA supplement is needed?

21 CFR 814.39(a)

What is the name of the branch that handles electronic comments?

Devices Branch

What is the use of a different facility or establishment to manufacture, process, or package the device?

manufacture, process, or package the device

What is the name of the periodic report that reports a change to a manufacturing procedure or method of manufacture that has been approved by FDA?

21 CFR 814.39(b)

What does the QS regulation require of you?

have in place a system to document and assess design changes

What is the primary indicator of what type of PMA submission is needed?

the nature of the data, if any, that is needed to demonstrate the safety and effectiveness of the modified device

What do we believe are needed to support the safety and effectiveness of such changes?

general nature of test data

What is the OIVD?

Safety

What is the purpose of the examples in this document?

to demonstrate the underlying principles

What is the term for in vitro diagnostics?

IDDs

What should you do when deciding whether to submit a supplement to your approved traditional PMA or to submit a new traditional PMA5 for a modified device?

ascertain whether, and to what extent, you can rely on the preclinical testing and clinical data submitted in your traditional PMA to support the safety and effectiveness of your modified device.

What does each example describe?

a device revie

What is the name of the Biological Markers and Clinical Endpoints?

6 1. Biomarker Tests

What is the procedure where the chest is opened by surgical incision?

TransMyocardial Revascularization (TMR) holmium laser

What is the laser penetrating entirely through the wall into the ventricular cavity?

hole

What is the term used to describe a study using a patient population with a defined clinical condition to determine the safety and effectiveness of the device?

clinical data

What is the PMA that is used in place of a traditional PMA?

modular PMA

What is PMR?

a non-surgical procedure

What was needed to assess the impact of the change in the device?

new preclinical testing

What was the purpose of the PMA?

Because new preclinical and clinical data were necessary to demonstrate a reasonable assurance of safety and effectiveness for the modification

What did the PMA applicant modify the lead by adding a steroid eluting piece to the distal lead tip to reduce?

the inflammatory process

What did the modified lead design raise questions about?

longer battery life and lower stimulation threshold

What was needed to demonstrate that the steroid-eluting lead remained as safe and effective as the approved non-steroid lead?

New preclinical and clinical data

What is IDEs?

Neurological Devices Targeting Disease Progression and Clinical Outcomes

What was the PMA meant to detect?

total prostate-specific antigen (total PSA) in serum

What were the analytical performance characteristics of the two assays?

differ

What is the OIVD?

Significant Modification of Technology

What is the name of the membrane-bound EIA?

membrane-bound EIA

What is the term for a panel-track supplement?

d

What is the MDTCA?

Medical Devices Technical Corrections Act

What describes when a Panel meeting may be held?

21 CFR 814.44

What is the term for a new clinical data set that is intended to provide valid scientific evidence necessary to support the safety and effectiveness of the modified device?

substantial clinical data

What is a nonbinding recommendation about the intended patient population?

null

What would generally require significant labeling changes?

Changes in these clinical aspects

What is the most appropriate supplement type for a change in indication for use or a change to (or removal of) a contraindication of the device?

panel-track supplement

What does novel treatments revolutionize?

how neurological diseases or conditions are treated

What is the FDA's view of a change in indication?

indication or contraindication changes generally do not require or require very limited new preclinical testing

What was the VAD indicated for?

temporary, mechanical circulatory support of nonreversible left ventricular failure in patients awaiting cardiac transplant

What are the two patient populations?

destination therapy patients are precluded from a transplant because they do not meet the age requirement or they have one or more co-morbid conditions (e.g., diabetes).

What was needed to demonstrate reasonable assurance of safety and effectiveness for longer term implantation?

New clinical data

What was the original PMA tested for?

safety and effectiveness

What was needed to support the safety and effectiveness of the device?

new clinical data

What was the original indication for urethral strictures?

the device is inserted into the bulbar urethra in order to improve urine flow and prevent recurrence of strictures

What is the new target patient population's risk related to?

age, overall health and anatomical location where the device is to be used

What is the risk of adverse tissue response due to the presence of the stent in hyperplastic tissue?

presence of the stent in hyperplastic tissue

What was the PMA approved for?

high frequency oscillatory ventilator

What is the FDA's role in the clinical trials of medical devices targeting neurological disease progression?

conduct clinical trials

What was the new indication for adults with adult respiratory distress syndrome?

adults with adult respiratory distress syndrome

What was needed to evaluate the safety and effectiveness of the device in the new population?

new clinical data

What did the PMA applicant modify to add pediatric patients?

the indication for use

What was the purpose of the new clinical testing?

to demonstrate that the device provided reasonable assurance of safety and effectiveness for the new pediatric patient population

What is nearsightedness?

myopia

What were concerns associated with the intrastomal ablation used in the new indication?

new risks and clinical effectiveness concerns

What was the PMA approved for?

a soft silicone hydrogel extended wear (1 to 7 days) contact lens indicated for the correction of myopia or hyperopia

What was the new safety concerns raised by the extended time of wear?

increased risk of ocular adverse events, such as corneal microbial keratitis, and corneal infiltrated lesions