Funybubble/fda · Datasets at Hugging Face

Question stringlengths 13 1.05k ⌀	Answer stringlengths 2 801 ⌀
What is the address of the Dockets Management Staff of the Food and Drug Administration?	5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852
What does not establish any rights for any person and is not binding on FDA or the public?	guidance
What is the IEC's standard 60825-1: Safety of laser products?	60825-1: Safety of laser products
What is the edition of IEC 60601-2-22 Ed. 2-22?	Medical electrical equipment
What does FDA's guidance documents, including this guidance, do not establish?	legally enforceable responsibilities
What does Laser product mean?	any manufactured product or assemblage of components which constitutes, incorporates, or is intended to incorporate a laser or laser system
What are the two definitions of a medical device and an electronic product?	201(h) and 531(2)
What did CDRH previously issue notices to?	laser product manufacturers and importers
What are the framework and associated analyses in this guidance potentially 196 applicable to?	such combination products
What does IEC stand for?	International Electrotechnical Commission
What may cause manufacturers to duplicate their efforts?	Complying with FDA regulations and conforming to the identified IEC standards
What does FDA acknowledge the advantages of?	one set of criteria and requirements worldwide
What is the chapter on Radiological Health in 21 CFR?	Subchapter J
What is the name of the guidance issued by FDA?	Laser Notice No. 56
What does FDA not intend to enforce if the laser product conforms to IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1?	applicable FDA requirements
What is the name of the IEC standard?	IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1
What is the equivalent clause to?	1040.10(b) Definitions 1040.10(c)(1) Classification* 1040.10(d) Accessible emission limits 1040.10(e) Tests for determination of compliance 1040.10(f)(1) Protective housing
What is the name of the document that specifies the interpretation sheets for laser products?	IEC-60601-2-22-laser-notice-no-50 3 Contains Nonbinding Recommendations 1040.10(f)(2) Safety interlocks** 1040.10(f)(3) Remote Interlock connector 1040.10(f)(4) Key control 1040.10(f)(5) Laser radiation emission indicator 1040.10(f)(6) Beam attenuator 1040.10(f)(7) Location of controls 1040.10(f)(8) Scanning safeguard 1040.11(a) Medical laser products *
What may FDA request from your product Classification Testing to confirm that the laser product is properly classified?	null
What indirectly requires redundancy or safe-failure for safety interlocks designed to protect against human?	IEC 60825-1 Ed. 3 (6.3)
What are the cases represented by?	hypothetical examples
What is the reasonably foreseeable single-fault condition sub-clause?	Classification Rules (4.3)
What may laser product manufacturers find useful for inclusion in correspondence and applications for variance or exemption?	this information
What are not comparable to FDA’s performance standards under 21 CFR 1040.10 and 1040.11?	IEC clauses and annexes
What does Sub-clause 3.25 (definition of collateral radiation) of IEC 60825-1 Ed. 3 not include?	all electromagnetic radiation (e.g., X-ray emissions) found in the FDA definition at 21 CFR 1040.10(b)(12)
What is not comparable to FDA’s performance standards?	Sub-clause 3.49 (definition of laser radiation) of IEC 60825-1 Ed. 3
What is the FDA definition of collateral radiation?	21 CFR 1040.10(b)(22)
What is the FDA's requirement that collateral radiation be measured separately when making classification measurements?	21 CFR 1040.10(c)
What does Clause 6.1 contain that manufacturers may find helpful?	ensuring that personnel responsible for classification receive training
What is the FDA performance standards for laser products not comparable to?	21 CFR 1040.10
What is mandatory in 21 CFR 1040.10(d)?	assessments of collateral radiation
What is the sub-clause 9.4 of the guidance on electric toys?	Sub-clause 9.4 Electric toys of IEC 60825-1 Ed. 3: For guidance on “electric toys,” please see FDA’s guidance entitled “Minimizing Risk for Children’s Toy Laser Products; Guidance for Industry and Food and Drug Administration Staff.”6 B. Performance Standards Not Subject to this Guidance
What are these FDA performance standards included as recommendations in?	User’s Guide clause of the IEC standards
What must the certification be provided on?	a label or tag permanently affixed to or inscribed on the product
What does Laser Notice No. 56 describe?	Conforms with 21 CFR 1040.10 and 1040.11 except for conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1
What should be documented and placed in the firm's records?	Testing results
What is the name of the document that contains Nonbinding Recommendations Medical X-Ray Imaging Devices Conformance with IEC Standards Guidance for Industry and Food and Drug Administration Staff Document issued on February 21, 2023?	null
What is the docket number of FDA-2016-D-2049?	FDA-2016-D-2049
What is the purpose of the EPRC Regulations?	Avoidance of Duplication
What is the name of the Clearance for Medical Devices?	510(k)
What does FDA encourage the applicant to conduct?	clinical studies
What does the guidance not establish any rights for?	any person
What is the FD&C Act?	Federal Food, Drug & Cosmetic Act
What must manufacturers and importers of medical x-ray imaging equipment follow?	current EPRC regulations and pr
What does FDA's guidance documents describe?	Agency's current thinking on a topic
What is the definition of an electronic product under the FD&C Act?	531(2)
What is the FDA is issuing this guidance to clarify?	relevant applicable standards
What is the second aspect of FDA categorizing medical devices?	Compliance with EPRC performance standards
What is the name of the section that regulates misbranding?	502
What is the general provisions of the FD&C Act?	general provisions
What is the minimum amount of a 510(k) submission required for Class I devices to be legally marketed?	o 21 CFR 820
What is the term for egulatory pathways?	egulatory pathways
What must manufacturers receive FDA approval of before marketing?	a premarket approval application
What must manufacturers and importers comply with?	applicable requirements
What is the 21 CFR Part 1004?	Repurchase, repairs, or replacement of electronic products
What is the name of the equipment that is used in the manufacture of microwave ovens?	Microwave ovens
What are the regulations and product codes for these devices in Tables 1 and 2?	Regulations and product codes
What is the name of the class of devices that are covered by thi?	Class II devices
What is the name of the radiographic film/cassette changer?	KPX
What is the name of the 510(k) process?	cleared for market
What does this guidance clarify?	relevant applicable voluntary consensus standards for medical x-ray systems and components
What is the part of IEC 60601-2-63 that contains Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment?	Part 2-63
What is the name of the document that describes the reclassification of Medical Image Analyzers?	“Radiology Devices; Reclassification of Medical Image Analyzers”
What is the initial plan to market the NME in?	prefilled 224 syringe
What is the minimum level of protection from electronic radiation that a manufacturer would have from IEC standards?	same level
What is the name of the transition period that is associated with the recognition of newer versions of consensus standards?	“Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices.”
What is the minimum level of protection from electronic product radiation?	conformance to the identified IEC standards
What is the EPRC requirement deemed to have met based on conformity to applicable IEC standard(s)?	EPRC requirements deemed to be met based on conformity to applicable IEC standard(s)
What is the name of the section that the FDA has determined is not adequately addressed?	section 3b
What is the section of the FD&C Act that is not deemed to have met the requirements?	Section 514(c)(1)(B)
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?	location of the image receptor
What must manufacturers establish to obtain 510(k) clearance?	substantia
What section of the FD&C Act supports a substantial equivalence?	513(i)
What is the route of administration of the drug?	subcutaneous
What must manufacturers and importers include a declaration of conformity as part of?	a premarket submission
What is the guidance entitled “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices”?	Information on such declarations is available in the guidance entitled “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices.”18 VI. Certification Manufacturers of diagnostic x-ray systems, and their major components, for which an applicable EPRC performance standard is in effect, including those that conform to applicable IEC standards to meet EPRC performance standards, must provide certifications for their products.
What must the certification be provided on?	a label or tag permanently affixed to or inscribed on a product
What is the FDA Recognized Standards Database available at?	ERROR: type should be string, got " https://www.fda.gov/regulatory-informati"
What does a CT device comply with?	21 CFR 1020.30
What is the 21 CFR 1010.2(c)?	this certification must be “based upon a test, in accordance with the standard, of the individual article to which it is attached or upon a testing program which is in accordance with good manufacturing pract”.
What should be documented and placed in the firm’s records?	Testing results
What does section 1020.30(g) help to ensure?	diagnostic x-ray equipment
What should a manufacturer include in their AIAT documentation?	Radiation Safety Specification and Testing Comparison Document
What does the autoinjector change about the method of injecting the drug constituent part?	238 injecting the drug constituent part
What is the purpose of the FDA's recommendation for manufacturers to format their AIAT documentation?	so that all radiation safety specifications and test methods, including acceptance and constancy testing, are available in a format that Answer: FDA recommends that manufacturers format their AIAT documentation so that all radiation safety specifications and test methods, including acceptance and constancy testing, are available in a format that Answer: FDA recommends that manufacturers format their AIAT documentation
What should the document include if the device does not otherwise meet EPRC performance standards?	radiation safety specifications
What is the name of the document that is being replaced by the IEC standard?	IEC standard
What is a manufacturer using a declaration of conformity to comply with certain requirements?	a declaration of conformity
What must a manufacturer's quality system address?	various aspects of radiation safety and conformity to standards
What does FDA find a manufacturer’s testing program does not assure the adequacy of safeguards against?	hazardous electronic product radiation
What is the FDA's guidance available at https://www.fda.gov/regulatory?	Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices
What is the purpose of testing that supports a declaration of conformity?	for more information about testing that supports a declaration of conformity
What must manufacturers and importers do when they discover a radiation safety defect?	notify FDA
What is the base standard of the IEC?	general standard
What may change the safety and effectiveness profile of the user interface?	The difference in the user interface design
What may replace, add to, amend, or remove conditions contained in the general or collateral standards?	Particular standards apply to specific types of equipment
What is conformance to a particular standard included in?	conformance to any collateral standards and the general standard in the same series
What does the far-left column list?	the classificat
What does the column marked with an ‘X’ provide?	the names of the IEC standards that apply to that device
What is the name of the equipment that is used in mammography?	KPX

What is the address of the Dockets Management Staff of the Food and Drug Administration?

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

What does not establish any rights for any person and is not binding on FDA or the public?

guidance

What is the IEC's standard 60825-1: Safety of laser products?

60825-1: Safety of laser products

What is the edition of IEC 60601-2-22 Ed. 2-22?

Medical electrical equipment

What does FDA's guidance documents, including this guidance, do not establish?

legally enforceable responsibilities

What does Laser product mean?

any manufactured product or assemblage of components which constitutes, incorporates, or is intended to incorporate a laser or laser system

What are the two definitions of a medical device and an electronic product?

201(h) and 531(2)

What did CDRH previously issue notices to?

laser product manufacturers and importers

What are the framework and associated analyses in this guidance potentially 196 applicable to?

such combination products

What does IEC stand for?

International Electrotechnical Commission

What may cause manufacturers to duplicate their efforts?

Complying with FDA regulations and conforming to the identified IEC standards

What does FDA acknowledge the advantages of?

one set of criteria and requirements worldwide

What is the chapter on Radiological Health in 21 CFR?

Subchapter J

What is the name of the guidance issued by FDA?

Laser Notice No. 56

What does FDA not intend to enforce if the laser product conforms to IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1?

applicable FDA requirements

What is the name of the IEC standard?

IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1

What is the equivalent clause to?

1040.10(b) Definitions 1040.10(c)(1) Classification* 1040.10(d) Accessible emission limits 1040.10(e) Tests for determination of compliance 1040.10(f)(1) Protective housing

What is the name of the document that specifies the interpretation sheets for laser products?

IEC-60601-2-22-laser-notice-no-50 3 Contains Nonbinding Recommendations 1040.10(f)(2) Safety interlocks** 1040.10(f)(3) Remote Interlock connector 1040.10(f)(4) Key control 1040.10(f)(5) Laser radiation emission indicator 1040.10(f)(6) Beam attenuator 1040.10(f)(7) Location of controls 1040.10(f)(8) Scanning safeguard 1040.11(a) Medical laser products *

What may FDA request from your product Classification Testing to confirm that the laser product is properly classified?

null

What indirectly requires redundancy or safe-failure for safety interlocks designed to protect against human?

IEC 60825-1 Ed. 3 (6.3)

What are the cases represented by?

hypothetical examples

What is the reasonably foreseeable single-fault condition sub-clause?

Classification Rules (4.3)

What may laser product manufacturers find useful for inclusion in correspondence and applications for variance or exemption?

this information

What are not comparable to FDA’s performance standards under 21 CFR 1040.10 and 1040.11?

IEC clauses and annexes

What does Sub-clause 3.25 (definition of collateral radiation) of IEC 60825-1 Ed. 3 not include?

all electromagnetic radiation (e.g., X-ray emissions) found in the FDA definition at 21 CFR 1040.10(b)(12)

What is not comparable to FDA’s performance standards?

Sub-clause 3.49 (definition of laser radiation) of IEC 60825-1 Ed. 3

What is the FDA definition of collateral radiation?

21 CFR 1040.10(b)(22)

What is the FDA's requirement that collateral radiation be measured separately when making classification measurements?

21 CFR 1040.10(c)

What does Clause 6.1 contain that manufacturers may find helpful?

ensuring that personnel responsible for classification receive training

What is the FDA performance standards for laser products not comparable to?

21 CFR 1040.10

What is mandatory in 21 CFR 1040.10(d)?

assessments of collateral radiation

What is the sub-clause 9.4 of the guidance on electric toys?

Sub-clause 9.4 Electric toys of IEC 60825-1 Ed. 3: For guidance on “electric toys,” please see FDA’s guidance entitled “Minimizing Risk for Children’s Toy Laser Products; Guidance for Industry and Food and Drug Administration Staff.”6 B. Performance Standards Not Subject to this Guidance

What are these FDA performance standards included as recommendations in?

User’s Guide clause of the IEC standards

What must the certification be provided on?

a label or tag permanently affixed to or inscribed on the product

What does Laser Notice No. 56 describe?

Conforms with 21 CFR 1040.10 and 1040.11 except for conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1

What should be documented and placed in the firm's records?

Testing results

What is the name of the document that contains Nonbinding Recommendations Medical X-Ray Imaging Devices Conformance with IEC Standards Guidance for Industry and Food and Drug Administration Staff Document issued on February 21, 2023?

null

What is the docket number of FDA-2016-D-2049?

FDA-2016-D-2049

What is the purpose of the EPRC Regulations?

Avoidance of Duplication

What is the name of the Clearance for Medical Devices?

510(k)

What does FDA encourage the applicant to conduct?

clinical studies

What does the guidance not establish any rights for?

any person

What is the FD&C Act?

Federal Food, Drug & Cosmetic Act

What must manufacturers and importers of medical x-ray imaging equipment follow?

current EPRC regulations and pr

What does FDA's guidance documents describe?

Agency's current thinking on a topic

What is the definition of an electronic product under the FD&C Act?

531(2)

What is the FDA is issuing this guidance to clarify?

relevant applicable standards

What is the second aspect of FDA categorizing medical devices?

Compliance with EPRC performance standards

What is the name of the section that regulates misbranding?

502

What is the general provisions of the FD&C Act?

general provisions

What is the minimum amount of a 510(k) submission required for Class I devices to be legally marketed?

o 21 CFR 820

What is the term for egulatory pathways?

egulatory pathways

What must manufacturers receive FDA approval of before marketing?

a premarket approval application

What must manufacturers and importers comply with?

applicable requirements

What is the 21 CFR Part 1004?

Repurchase, repairs, or replacement of electronic products

What is the name of the equipment that is used in the manufacture of microwave ovens?

Microwave ovens

What are the regulations and product codes for these devices in Tables 1 and 2?

Regulations and product codes

What is the name of the class of devices that are covered by thi?

Class II devices

What is the name of the radiographic film/cassette changer?

KPX

What is the name of the 510(k) process?

cleared for market

What does this guidance clarify?

relevant applicable voluntary consensus standards for medical x-ray systems and components

What is the part of IEC 60601-2-63 that contains Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment?

Part 2-63

What is the name of the document that describes the reclassification of Medical Image Analyzers?

“Radiology Devices; Reclassification of Medical Image Analyzers”

What is the initial plan to market the NME in?

prefilled 224 syringe

What is the minimum level of protection from electronic radiation that a manufacturer would have from IEC standards?

same level

What is the name of the transition period that is associated with the recognition of newer versions of consensus standards?

“Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices.”

What is the minimum level of protection from electronic product radiation?

conformance to the identified IEC standards

What is the EPRC requirement deemed to have met based on conformity to applicable IEC standard(s)?

EPRC requirements deemed to be met based on conformity to applicable IEC standard(s)

What is the name of the section that the FDA has determined is not adequately addressed?

section 3b

What is the section of the FD&C Act that is not deemed to have met the requirements?

Section 514(c)(1)(B)

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?

location of the image receptor

What must manufacturers establish to obtain 510(k) clearance?

substantia

What section of the FD&C Act supports a substantial equivalence?

513(i)

What is the route of administration of the drug?

subcutaneous

What must manufacturers and importers include a declaration of conformity as part of?

a premarket submission

What is the guidance entitled “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices”?

Information on such declarations is available in the guidance entitled “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices.”18 VI. Certification Manufacturers of diagnostic x-ray systems, and their major components, for which an applicable EPRC performance standard is in effect, including those that conform to applicable IEC standards to meet EPRC performance standards, must provide certifications for their products.

What must the certification be provided on?

a label or tag permanently affixed to or inscribed on a product

What is the FDA Recognized Standards Database available at?

ERROR: type should be string, got " https://www.fda.gov/regulatory-informati"

What does a CT device comply with?

21 CFR 1020.30

What is the 21 CFR 1010.2(c)?

this certification must be “based upon a test, in accordance with the standard, of the individual article to which it is attached or upon a testing program which is in accordance with good manufacturing pract”.

What should be documented and placed in the firm’s records?

Testing results

What does section 1020.30(g) help to ensure?

diagnostic x-ray equipment

What should a manufacturer include in their AIAT documentation?

Radiation Safety Specification and Testing Comparison Document

What does the autoinjector change about the method of injecting the drug constituent part?

238 injecting the drug constituent part

What is the purpose of the FDA's recommendation for manufacturers to format their AIAT documentation?

so that all radiation safety specifications and test methods, including acceptance and constancy testing, are available in a format that Answer: FDA recommends that manufacturers format their AIAT documentation so that all radiation safety specifications and test methods, including acceptance and constancy testing, are available in a format that Answer: FDA recommends that manufacturers format their AIAT documentation

What should the document include if the device does not otherwise meet EPRC performance standards?

radiation safety specifications

What is the name of the document that is being replaced by the IEC standard?

IEC standard

What is a manufacturer using a declaration of conformity to comply with certain requirements?

a declaration of conformity

What must a manufacturer's quality system address?

various aspects of radiation safety and conformity to standards

What does FDA find a manufacturer’s testing program does not assure the adequacy of safeguards against?

hazardous electronic product radiation

What is the FDA's guidance available at https://www.fda.gov/regulatory?

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices

What is the purpose of testing that supports a declaration of conformity?

for more information about testing that supports a declaration of conformity

What must manufacturers and importers do when they discover a radiation safety defect?

notify FDA

What is the base standard of the IEC?

general standard

What may change the safety and effectiveness profile of the user interface?

The difference in the user interface design

What may replace, add to, amend, or remove conditions contained in the general or collateral standards?

Particular standards apply to specific types of equipment

What is conformance to a particular standard included in?

conformance to any collateral standards and the general standard in the same series

What does the far-left column list?

the classificat

What does the column marked with an ‘X’ provide?

the names of the IEC standards that apply to that device

What is the name of the equipment that is used in mammography?

KPX