Question stringlengths 13 1.05k ⌀ | Answer stringlengths 2 801 ⌀ |
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What is the name of the guidance that A’s issued for Medical Device Manufacturers? | General Principles of Software Validation |
What are the majority of class I devices exempt from? | the premarket submission requirements |
What is the FDA's classification of devices? | Some FDA classifi |
What does a 510(k) exempt mean? | the manufacturer is not required to submit a premarket notification (i.e., a 510(k)) prior to marketing the device |
What is the webpage that contains additional information about 510(k) exempt devices? | “Medical Device Exemptions 510(k) and GMP Requirements” |
What is the process for determining whether a reader’s interpretation corresponds to the truth status established during the truthing process? | rationale, definition, and criteria |
What is my app considered? | a mobile medical app |
What are apps from a device manufacturer that provide information to support the company’s own device? | mobile medical apps |
What is not considered on its own to be a device software? | Software used for data collection in clinical studies |
What is the name of the FDA guidance document that contains Nonbinding Recommendations function? | FDA’s guidance related to use of computers |
What is the name of the study that was issued on September 17, 2013? | Electronic Source Data in Clinical Investigations |
What does ANSI stand for? | American National Standards Institute |
What is the ISO 9001 Quality management system? | Requirements |
What is the IEEE Standard for System, Software, and Hardware Verification and Validation? | IEEE Std 1012 |
What is the name of the Part 1 of the Guidance on the application of ISO 14971 to medical device software? | IEC/TR 80002-1 |
What is the part of the IEC 61508-2 that describes the Functional safety of electrical/electronic/programmable electronic safety-related systems? | Part 2: Requirements for electrical/electronic/programmable electronic safety-related systems |
What should you describe and fix before initiating your evaluation? | the scoring process |
What is the name of the division that provides education about CDRH-regulated devices? | Division of Industry and Consumer Education (DICE) |
What is the address of the Dockets Management Staff, Food and Drug Administration? | 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852 |
What is the address of the OCOD? | 10903 New Hampshire Ave., WO71, Room 3128, Silver Spring, MD 20903 |
What is the address for De Novo Requests? | Address |
What act was passed in 1995? | Paperwork Reduction Act of 1995 |
What is the purpose of this document? | to provide guidance on the process for the submission and review of a De Novo classification request |
What does the De Novo classification process provide a pathway to? | class I or class II classification |
What does CBER stand for? | Biologics Evaluation and Research |
What is a device classified in class III and subject to premarket approval? | class III |
What is the risk of a new type of device? | the device and the inability of general and special controls to provide reasonable assurance of the safety and effectiveness of the device |
What is the physical overlap of the boundary, area, or volume of a reader mark in relation to the boundary, area, or volume of reference standard? | physical overlap |
What is the level of risk they pose or the ability of general and special controls to assure safety and effectiveness? | level of risk |
What was the process created by section 513(f)(2) of the FD&C Act referred to as in FDAMA? | Evaluation of Automatic Class III Designation |
What had to be found in order to submit a De Novo request? | not substantiated |
What is a premarket notification? | 510(k) |
What did FDA reclassify devices under? | section 513(e) of the FD&C Act |
What is the name of the nonbinding recommendations currently available informatio? | Nonbinding Recommendations |
What is the name of the subpart that FDA will use to assess whether a request for an evaluation of automatic class III designation is granted? | 21 CFR Part 860, Subpart D--De Novo Classification |
What is the name of the new section that FDA is updating to reflect the De Novo final rule? | 513(f)(2) – Evaluation of Automatic Class III Designation, Guidance for Industry and CDRH Staff |
What must the FDA make a classification determination for? | the de: FDA must make a classification determination for the de: FDA must make a classification determination for the de: FDA must make a classification determination for the de: FDA must make a classification determination for the de: FDA must make a classification determination for the de: FDA must make a classification determination for the de: FDA must make a classification determination for the de: FDA must describe the device and detailed information and reasons for any recommended classification |
What is the subject of the De Novo request by written order within 120 days of receipt of the request? | the subject of the De Novo request |
What should you describe when multiple readers are involved in scoring? | the number of readers involved, their qualifications, their levels of experience and expertise |
What is the device in class III and may not be marketed unless the device i i? | the device i |
What is the definition of a De Novo request? | a new De Novo request |
What will FDA consider a De Novo request for? | devices that have already undergone 510(k) review |
What should appear to meet the statutory standards for classification into class I or class II under section 513(a)(1) of the FD&C Act? | general controls or general and special controls would provide reasonable assurance of the safety and e |
What allows FDA to provide feedback on whether a device may be eligible for the De Novo classification process? | A Pre-Sub |
What is the purpose of a Pre-Sub? | to obtain feedback on the evidence, including non-clinical and/or clinical data, that will likely be necessary to support the De Novo request |
What is a Pre-Sub? | A Pre-Sub |
What will be handled in accordan? | De Novo Pre-Subs |
What does the FDA search to establish that no legally marketed device and no classification regulation for the same device type exists? | public databases |
What should clinical readers learn about the CADe device? | a description of the device and instructions for how to use the device |
What should the Pre- Sub include in order for us to consider the specific questions? | Specific questions regarding review issues relevant to a planned De Novo request |
What type of evidence do you anticipate providing in your De Novo request? | valid scientific evidence |
What is the proposed mitigation measure(s)/control(s) for each risk based on? | the best available information at the time of the submission |
What is the special use of a device? | mitigations |
What are there other risks, in addition to those identified in the Pre-Sub? | identified in the Pre-Sub |
What would be appropriate if additional biocompatibility and/or sterility testing were needed? | additional biocompatibility and/or sterility testing |
What is the name of the document that describes meetings with FDA staff? | Q-Sub Guidance |
What is the De Novo review process outlined in? | Attachment 1 |
What is the name of the website that provides information on vaccines and bloodbiologics? | CBER |
What is the required content for a De Novo request? | 21 CFR 860.220 |
What do you justify in your reading instructions? | clinical relevance |
What is the eCopy program for Medical Device Submissions? | eCopy Program for Medical Device Submissions |
What is the current mailing address for De Novo Requests? | current mailing address |
What is the NSE of a device? | general controls or general and special controls may provide reasonable assurance of safety and effectiveness |
What does the inclusion of this language within an NSE letter indicate? | given the risk profile of the device, it seems reasonable that De Novo classification may be appropriate |
What is the criteria for whether a De Novo request should be reviewed? | 11 |
What happens if your De Novo request is not accepted for review? | the review clock stops and we will notify you that it is on hold pending receipt of additional information |
What is the deadline for FDA to complete the acceptance review? | 15 days |
What is the purpose of the De Novo classification process? | to analyze whether a likely predicate device exists or your device falls under a class III classification regulation |
What will FDA inform you of in your De Novo request, including each applicable ground for declining the De Novo request? | null |
What is the purpose of an AI letter? | If the De Novo request is missing information and/or data necessary to determine whether general controls or general and special controls can provide reasonable assurance of safety and effectiveness |
What does reader training help avoid? | incorrect or un-interpretable results |
What will resume once you provide a complete response? | review |
What is the reason a De Novo request may be declined? | lack of performance data |
What is the name of the section that allows a De Novo request to be granted? | section 515 of the FD&C Act |
What is the classification of class II devices? | special controls |
What is the result of the final order in the Federal Register providing public notice of the decision? | codification of the device’s identification, classification, and applicable requirements in Title 21 of the Code of Federal Regulations |
What is the name of the website that we intend to make the summary of our review available on? | CDRH website |
What will be redacted to protect any confidential commercial, trade secret, or personal privacy information in accordance with 21 CFR Part 20.? | null |
What may the submitter of the declined De Novo request do? | leverage all information in the De Novo request by incorporating it by reference in a new 510(k) submission |
What is the FDA's guidance on De Novo Classification Requests? | FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals |
What is the OMB subject to review? | Paperwork Reduction Act of 1995 |
What is the name of the FDA Office responsible for this guidance? | Office responsible for this guidance as listed on the title page |
What is permissible for an efficient and less burdensome representative case data set? | Enrichment with diseased/abnormal cases |
What is the FDA's responsibility to the public regarding information collection? | complete and review the information collection |
What is the current expiration date? | 0910-0844 |
What is the minimum amount of FDA calendar days to Grant/ Decline FDA Substantive Review Additional information (AI)? | 120 FDA calendar days |
When was the document issued? | September 27, 2023 |
What is the name of the U.S. Department of Health and Human Services Office of Communication, Outreach, and Development (OCOD)? | OCOD |
Where can you find the FDA docket number? | 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852 |
What is the name of the office that provides the Gui00001825? | Office of Communication, Outreach, and Development |
What is the name of the document that is used to manage cybersecurity risks? | SPDF |
What is the name of the organization that manages the TPLC Security Risk Management? | 19 B. Security Architecture |
What is the name of the appendix that contains the Security Control Categories and Associated Recommendations? | Appendix 1 |
What will introduce biases into the study design? | stress testing |
What is the name of the document that is used to submit a Security Architecture Flows submission? | Submission Documentation for Security Architecture Flows |
What does not establish any rights for any person and is not binding on FDA or the public? | It does not establish any rights for any person and is not binding on FDA or the public |
What is the need for robust cybersecurity controls to ensure? | medical device safety and effectiveness |
What may lead to patient harm as a result of clinical hazards? | cyber attacks and exploits |
What does ensuring device safety and effectiveness include? | adequate device cybersecurity |
What is the name of the organization that reviews Regulatory Submissions? | Center for Biologics Evaluation and Research |
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