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... |
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 effe... |
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, ar... |
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 |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.