Funybubble/fda · Datasets at Hugging Face

Question stringlengths 13 1.05k ⌀	Answer stringlengths 2 801 ⌀
What do IEC standards 60601-2-63 and 60601-2-65 use to determine whether the device is an extra-oral device or an intra- oral device?	the location of the image receptor
What is the applicable standard for all other devices under 21 CFR 892.1650?	IEC 60601-2-54
What is the name of the Nonbinding Recommendations Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring Guidance for Industry and Food and Drug Administration Staff Document issued on October 19, 2023.?	null
When was the COVID-19 Public Health Emergency issued?	March 2020
What is the CMC?	chemistry, manufacturing, and controls
What is the docket number of FDA-2023-D-4356?	FDA-2023-D-4356
What is the document number for the guidance?	GUI00020014
What does the guidance not establish any rights for?	any person
What is the FDA's role in protecting the United States from?	emerging infectious diseases
What was the purpose of this guidance?	to provide a policy to help expand the availability and capability of non-invasive remote monitoring devices to address the PHE
How long does the guidance document continue in effect after the COVID-19 PHE declaration expire?	180 days
What is the name of the guidance document that is intended to facilitate patient monitoring while reducing patient and healthcare provider?	COVID-19
When did the Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring expire?	May 11, 2023)
What has FDA evaluated the benefits and risks to patients and healthcare providers of exercising certain enforcement policies?	exercised certain enforcement policies
What do we recommend you include if submitting a Declaration of Conformity to a recognized standard?	appropriate supporting documentation
What is the autoinjector designed to meet a specific injection time specification?	autoinjector
What has FDA determined about the use of consensus standards in regulatory submissions?	prior public participation for this guidance is not feasible or appropriate
What is the guidance document being implemented immediately?	this guidance document
Where can you find the Agency guidance?	ERROR: type should be string, got " https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm"
What does the inal device measure?	common physiological parameters
What is the name of the pressure measurement system used in the CFR?	Noninvasive blood
What is the name of the section of the FD&C Act that exempts devices with the product codes listed in Table 1?	510(k)
What are the two types of stethoscopes covered by this classification regulation?	manual and electronic
What is the name of the 510(k) exempt system that PKQ II cognitive assessment is exempt from?	PTY II
What is not exempt from 510(k) of the FD&C Act?	otoacoustic emission devices
What is the time of injection that determines the rate of drug delivery?	266 injection time
What does FDA believe may trigger the requirement that a manufacturer submit a premarket notification?	modifications to existing otoscopes to allow for increased remote monitoring capability
What is exempt from premarket notification requirements?	computerized cognitive assessment aid
What is the requirement for marketing new devices within this device type Until the unclassified device type has been classified through regulation?	null
What is the name of the non-invasive monitoring device that can be connected to a wireless network to transmit a patient’s measurements directly to their healthcare provider?	The Oximeter
What is the name of the non-invasive remote monitoring device that was removed from Table 1 compared to previous versions of FDA’s guidance?	Clinical electronic thermometer
What does FDA not intend to object to?	limited modifications to the indications, functionality, or hardware or software of certain non-invasive remote monitoring devices
What is a premarket notification called?	510(k)
What is CDRH's 2022-2025 strategic priorities?	focusing on advancing health equity
What can advance better care, quality of life, and wellness of diverse populations?	digital health technologies
What may require premarket notification if modifications to the indications, functionality, or hardware or software of 510(k)-exempt devices in Table 1 may require?	null
What is the policy supporting?	this strategic priority
What did the applicant conduct with the PFS presentation?	phase 3 studies
What does the enforcement policy in this guidance address?	premarket notification
What would not be within the scope of th FDA?	modifications to the indications or functionality that could create such undue risk or that could affect the physiological parameter measurement algorithm
What would not be within the scope of this policy?	modifications to add new indications or device software functions
What is a distinct purpose of the product?	function
What is a “device software function”?	a software function that meets the definition of a device under section 201(h) of the FD&C Act
What is the 21 CFR 801.5?	describes a number of reasons why directions for use may be inadequate
What is the purpose of the information on the device?	Information on use conditions
What should the manufacturer consider in Section III.A?	hardware or softwar
What is a common reason for device hardware or software architecture modifications?	may warrant accompanying non-device22 and device hardware or software architecture modifications
What does not affect the physiological parameter measurement algorithm?	such a change would generally be within the scope of this policy
What do constituent parts of a combination product retain after they are combined?	regulatory status
What is the Collateral Standard for Electromagnetic Disturbances?	Electromagnetic Disturbances
What is the FDA's guidance on Medical Image Communications Devices?	Medical Image Communications Devices
What is the Collateral Standard for?	Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment
What is the AIM 7351731 Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers?	AIM 7351731
What is the part 5-1 of IEC 81001-5-1 for?	Security
What is effective cybersecurity necessary to ensure?	the safety and functionality of such devices
What is the CGMP requirement of the QS regulation?	good manufacturing practice
What did FDA want to incorporate by reference?	2016 edition of the International Organization for Standardization (ISO) 13485
What is the name of the part of the proposed rule that specifies the requirements for quality management systems for Medical devices?	part 820
What is the FDA's role in Medical Device Cybersecurity?	The FDA’s Role in Medical Device Cybersecurity
What may manufacturers meet under a streamlined approach?	drug CGMPs and device quality system QS regulation
What is the name of the document that the FDA issued on July 1, 2020?	Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking
What is the name of the U.S. Department of Health and Human Services Center for Devices and Radiological Health Center for Biologics Evaluation and Research?	OCOD
What is the name of the office that FDA is in charge of approving comments to the document?	5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852
What is the OCOD?	Office of Communication, Outreach, and Development
What is the Policy Answer: Compliance Policy for GUDID Submission Requirements for Class I Devices?	null
What are the Class III, LS/LS, and Class II Non-Sterile Devices Manufactured and Labeled Prior to the Established Direct Mark Compliance Date That Remain in Inventory?	Class III, LS/LS, and Class II Non-Sterile Devices
What does the guidance not establish any rights for?	any person
What is FDA's unique device identification system designed to adequately identify?	devices through distribution and use
What is Section 519(f) of the Federal Food, Drug, and Cosmetic Act?	UDI system regulations
What can a labeler of a class I device determine?	whether its device is within the scope of that compliance policy
What is the classification of CADe devices?	21 CFR 892.2050
What is the procurement controls of the CGMP?	21 CFR 820.50
What do the terms "you" and "your" refer to in this guidance document?	the labeler
What is the FDA determined is a less burdensome policy that is consistent with public health?	this approach
What is the guidance subject to comment in accordance with?	the Agency’s good guidance practices
What should be viewed as recommendations?	FDA guidance documents
What is the name of the rule that the FDA published on September 24, 2013?	UDI system
What is the range of compliance dates for the UDI Rule?	September 24, 2014, to September 24, 2020
What is the UDI Rule also required that data pertaining to the key characteristics of each device required to bear a UDI be submitted to?	FDA’s GUDID
What did FDA align the compliance date for standard date format requirements with?	compliance date by which a device must bear a UDI on its label and packages
What does the UDI system seek to improve?	the identification of medical devices
What is the UDI policy regarding?	Compliance Dates for Class I and Unclassified Devices
What is the focus of design control discussion in this guidance?	the information required to demonstrate that the final combination product achieves its identified performance
What did the prior versions of this guidance reflect?	our belief that it was important to continue focusing our resources on addressing UDI implementation issues and data quality for higher risk devices
What is the lowest risk of UDI devices?	class I devices
What is the UPC used for?	a barcode
What is the public benefit of GUDID submission for consumer health products?	public health benefit
What does FDA not intend to enforce for consumer health products?	GUDID submission requirements
What was the prior version of the guidance that FDA did not intend to enforce?	direct mark requirements
What is the UDI Rule for class I devices?	the UDI Rule
What are typically used in healthcare settings and are often subject to additional regulatory controls?	These devices are typically used in healthcare settings
What is the purpose of the submission of UDI data into GUDID?	to evaluate and improve device safety throughout the product lifecycle
What did FDA say in the 2020 UDI Compliance Policy Guidance?	we did not intend to enforce the GUDID submission requirements under 21 CFR 830.300 for class I and unclassified devices, other than I/LS/LS devices
What are some of the data needed to make such design verification and validation demonstrations?	bench data, preclinical/clinical testing data, and human factors (HF) studies
What does 21 CFR 830.300 require for class I and unclassified devices?	GUDID submission requirements
What is the name of the device that is manufactured and labeled before the labeler has implemented direct marking?	finished devices
What can entail different design changes and design validations than those made in order to add a required UDI direct mark to future lots of the device?	remediating existing devices in inventory
What may be used to facilitate recalls and medical device reporting, in analysis of premarket approval application (PMA) annual reports, and for other FDA processes?	GUDID data
What is the tail of the 85 FR 39477?	tail
What is the compliance date for class I and unclassified devices?	21 CFR 801.20

What do IEC standards 60601-2-63 and 60601-2-65 use to determine whether the device is an extra-oral device or an intra- oral device?

the location of the image receptor

What is the applicable standard for all other devices under 21 CFR 892.1650?

IEC 60601-2-54

What is the name of the Nonbinding Recommendations Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring Guidance for Industry and Food and Drug Administration Staff Document issued on October 19, 2023.?

null

When was the COVID-19 Public Health Emergency issued?

March 2020

What is the CMC?

chemistry, manufacturing, and controls

What is the docket number of FDA-2023-D-4356?

FDA-2023-D-4356

What is the document number for the guidance?

GUI00020014

What does the guidance not establish any rights for?

any person

What is the FDA's role in protecting the United States from?

emerging infectious diseases

What was the purpose of this guidance?

to provide a policy to help expand the availability and capability of non-invasive remote monitoring devices to address the PHE

How long does the guidance document continue in effect after the COVID-19 PHE declaration expire?

180 days

What is the name of the guidance document that is intended to facilitate patient monitoring while reducing patient and healthcare provider?

COVID-19

When did the Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring expire?

May 11, 2023)

What has FDA evaluated the benefits and risks to patients and healthcare providers of exercising certain enforcement policies?

exercised certain enforcement policies

What do we recommend you include if submitting a Declaration of Conformity to a recognized standard?

appropriate supporting documentation

What is the autoinjector designed to meet a specific injection time specification?

autoinjector

What has FDA determined about the use of consensus standards in regulatory submissions?

prior public participation for this guidance is not feasible or appropriate

What is the guidance document being implemented immediately?

this guidance document

Where can you find the Agency guidance?

ERROR: type should be string, got " https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm"

What does the inal device measure?

common physiological parameters

What is the name of the pressure measurement system used in the CFR?

Noninvasive blood

What is the name of the section of the FD&C Act that exempts devices with the product codes listed in Table 1?

510(k)

What are the two types of stethoscopes covered by this classification regulation?

manual and electronic

What is the name of the 510(k) exempt system that PKQ II cognitive assessment is exempt from?

PTY II

What is not exempt from 510(k) of the FD&C Act?

otoacoustic emission devices

What is the time of injection that determines the rate of drug delivery?

266 injection time

What does FDA believe may trigger the requirement that a manufacturer submit a premarket notification?

modifications to existing otoscopes to allow for increased remote monitoring capability

What is exempt from premarket notification requirements?

computerized cognitive assessment aid

What is the requirement for marketing new devices within this device type Until the unclassified device type has been classified through regulation?

null

What is the name of the non-invasive monitoring device that can be connected to a wireless network to transmit a patient’s measurements directly to their healthcare provider?

The Oximeter

What is the name of the non-invasive remote monitoring device that was removed from Table 1 compared to previous versions of FDA’s guidance?

Clinical electronic thermometer

What does FDA not intend to object to?

limited modifications to the indications, functionality, or hardware or software of certain non-invasive remote monitoring devices

What is a premarket notification called?

510(k)

What is CDRH's 2022-2025 strategic priorities?

focusing on advancing health equity

What can advance better care, quality of life, and wellness of diverse populations?

digital health technologies

What may require premarket notification if modifications to the indications, functionality, or hardware or software of 510(k)-exempt devices in Table 1 may require?

null

What is the policy supporting?

this strategic priority

What did the applicant conduct with the PFS presentation?

phase 3 studies

What does the enforcement policy in this guidance address?

premarket notification

What would not be within the scope of th FDA?

modifications to the indications or functionality that could create such undue risk or that could affect the physiological parameter measurement algorithm

What would not be within the scope of this policy?

modifications to add new indications or device software functions

What is a distinct purpose of the product?

function

What is a “device software function”?

a software function that meets the definition of a device under section 201(h) of the FD&C Act

What is the 21 CFR 801.5?

describes a number of reasons why directions for use may be inadequate

What is the purpose of the information on the device?

Information on use conditions

What should the manufacturer consider in Section III.A?

hardware or softwar

What is a common reason for device hardware or software architecture modifications?

may warrant accompanying non-device22 and device hardware or software architecture modifications

What does not affect the physiological parameter measurement algorithm?

such a change would generally be within the scope of this policy

What do constituent parts of a combination product retain after they are combined?

regulatory status

What is the Collateral Standard for Electromagnetic Disturbances?

Electromagnetic Disturbances

What is the FDA's guidance on Medical Image Communications Devices?

Medical Image Communications Devices

What is the Collateral Standard for?

Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment

What is the AIM 7351731 Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers?

AIM 7351731

What is the part 5-1 of IEC 81001-5-1 for?

Security

What is effective cybersecurity necessary to ensure?

the safety and functionality of such devices

What is the CGMP requirement of the QS regulation?

good manufacturing practice

What did FDA want to incorporate by reference?

2016 edition of the International Organization for Standardization (ISO) 13485

What is the name of the part of the proposed rule that specifies the requirements for quality management systems for Medical devices?

part 820

What is the FDA's role in Medical Device Cybersecurity?

The FDA’s Role in Medical Device Cybersecurity

What may manufacturers meet under a streamlined approach?

drug CGMPs and device quality system QS regulation

What is the name of the document that the FDA issued on July 1, 2020?

Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking

What is the name of the U.S. Department of Health and Human Services Center for Devices and Radiological Health Center for Biologics Evaluation and Research?

OCOD

What is the name of the office that FDA is in charge of approving comments to the document?

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

What is the OCOD?

Office of Communication, Outreach, and Development

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

null

What are the Class III, LS/LS, and Class II Non-Sterile Devices Manufactured and Labeled Prior to the Established Direct Mark Compliance Date That Remain in Inventory?

Class III, LS/LS, and Class II Non-Sterile Devices

What does the guidance not establish any rights for?

any person

What is FDA's unique device identification system designed to adequately identify?

devices through distribution and use

What is Section 519(f) of the Federal Food, Drug, and Cosmetic Act?

UDI system regulations

What can a labeler of a class I device determine?

whether its device is within the scope of that compliance policy

What is the classification of CADe devices?

21 CFR 892.2050

What is the procurement controls of the CGMP?

21 CFR 820.50

What do the terms "you" and "your" refer to in this guidance document?

the labeler

What is the FDA determined is a less burdensome policy that is consistent with public health?

this approach

What is the guidance subject to comment in accordance with?

the Agency’s good guidance practices

What should be viewed as recommendations?

FDA guidance documents

What is the name of the rule that the FDA published on September 24, 2013?

UDI system

What is the range of compliance dates for the UDI Rule?

September 24, 2014, to September 24, 2020

What is the UDI Rule also required that data pertaining to the key characteristics of each device required to bear a UDI be submitted to?

FDA’s GUDID

What did FDA align the compliance date for standard date format requirements with?

compliance date by which a device must bear a UDI on its label and packages

What does the UDI system seek to improve?

the identification of medical devices

What is the UDI policy regarding?

Compliance Dates for Class I and Unclassified Devices

What is the focus of design control discussion in this guidance?

the information required to demonstrate that the final combination product achieves its identified performance

What did the prior versions of this guidance reflect?

our belief that it was important to continue focusing our resources on addressing UDI implementation issues and data quality for higher risk devices

What is the lowest risk of UDI devices?

class I devices

What is the UPC used for?

a barcode

What is the public benefit of GUDID submission for consumer health products?

public health benefit

What does FDA not intend to enforce for consumer health products?

GUDID submission requirements

What was the prior version of the guidance that FDA did not intend to enforce?

direct mark requirements

What is the UDI Rule for class I devices?

the UDI Rule

What are typically used in healthcare settings and are often subject to additional regulatory controls?

These devices are typically used in healthcare settings

What is the purpose of the submission of UDI data into GUDID?

to evaluate and improve device safety throughout the product lifecycle

What did FDA say in the 2020 UDI Compliance Policy Guidance?

we did not intend to enforce the GUDID submission requirements under 21 CFR 830.300 for class I and unclassified devices, other than I/LS/LS devices

What are some of the data needed to make such design verification and validation demonstrations?

bench data, preclinical/clinical testing data, and human factors (HF) studies

What does 21 CFR 830.300 require for class I and unclassified devices?

GUDID submission requirements

What is the name of the device that is manufactured and labeled before the labeler has implemented direct marking?

finished devices

What can entail different design changes and design validations than those made in order to add a required UDI direct mark to future lots of the device?

remediating existing devices in inventory

What may be used to facilitate recalls and medical device reporting, in analysis of premarket approval application (PMA) annual reports, and for other FDA processes?

GUDID data

What is the tail of the 85 FR 39477?

tail

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

21 CFR 801.20