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What is the FDA unsure of?
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whether the device type can be safe and effective
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What is a factor in evaluating whether or not an IDE device receives Medicare coverage?
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CMS uses FDA’s categorization determination
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What is the criteria for a Category A device?
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42 CFR 405.212
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What does 42 CFR 405.211(b) do?
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Contains Nonbinding Recommendations Category A (Experimental) IDE study, but not the device itself
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What is the name of the document that provides guidance on the development and review of IDE applications for early feasibility studies?
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IDEs
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What are feasibility studies intended to provide?
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proof of principle and initial clinical study data
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What is the most common submission type for CADe devices addressed in this guidance?
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A 510(k) submission
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What are clinical investigations designed to collect definitive evidence of the safety and effectiveness of a device for a specified intended use?
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Pivotal studies
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What is the category designation based on?
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the criteria described in this document
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What did the IA not describe?
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a pathway for chang
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What did CMS change in January of 2015?
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42 CFR 405.211(a)
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What did CMS and FDA need to revisit to ensure reimbursement of devices will not be precluded due to an inappropriate reimbursement categorization determination?
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their shared understanding
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What is the definition of an IDE application?
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approved with conditions
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What is the FDA unsure if the device type can be safe and effective?
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whether the device type can be safe and effective
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What is being studied for a new indication?
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The proposed device
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What is the FDA Guidance document called?
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FDA Decisions for Investigational Device Exemption Clinical Investigations
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What does the FD&C Act stand for?
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Food, Drug, and Cosmetic Act
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What does the proposed device have different compared to a legally marketed device?
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technological characteristics
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What is the primary risk in question for a device?
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the incremental risk
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What resolves the initial questions of safety and effectiveness?
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available information (e.g., feasibility study data) from the proposed device or a similar device
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What may also have been used to resolve these questions?
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additional non-clinical and/or clinical data
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What can come from different sources and become available at different points in time?
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Data
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What is the name of the stage of a clinical study on the investigational device?
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a stage of a clinical study
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What may be warranted when an IDE study receives a staged approval?
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category change
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What may resolve initial questions of safety and effectiveness?
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data gathered from the first (or subsequent) enrollment stage(s)
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What is a categorization decision made upon study approval?
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a new study
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What should the supplement include that would support meeting the criteria as identified in 42 CFR 405.201(b)?
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data which would support a change from Category A to Category B
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What is a complex relationship between the CADe output and the clinician such that clinical performance may depend on a variety of factors that should be considered in any study design?
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timing of CA Answer: timing of CA: timing of CA: timing of CA: timing of CA: timing of CA: timing of CA: timing of CA: timing of CA: timing of CA: timing of CA: timing of CA: timing of CA: timing of CA: timing of CA: timing of CA: timing of CA: timing of CA: timing of CA: timing of CA: timing of CA: timing of CA: timing of CA: timing of CA: timing of CA: timing of CA: timing of CA: timing of CA: timing of CA: timing
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What is included as supportive information?
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Additional non-clinical data on the same or a similar device
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What may also change from B to A?
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category designation
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What is the name of the document that the sponsor must send to CMS to determine the categorization decision?
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IDE (original or supplement) approval letter
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What is the definition of Category A?
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completely novel and has no, or limited, previous human use
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What is not available to address the initial questions of safety and effectiveness associated with the addition of the drug?
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relevant non-clinical or clinical data
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What is the device’s technology unchanged from?
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what was initially approved or cleared
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What is the initial question that FDA is unsure whether or not the device type can be safe and effective?
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effectiveness
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What is inadequate 11 Contains Nonbinding Recommendations evidence to resolve initial questions related to safety because this will require follow up in a clinical study?
| null |
What did the non-clinical test data resolve?
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initial questions of safety and effectiveness related to this change
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What will be studied for an indication for which substantial safety and effectiveness information exists from other similar device(s) of the same type that are used for the same?
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A new device
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What is the name of the FDA's room 1061?
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HFA-305
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What should be used to preclude or limit biases that might impact conclusions?
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well-controlled study design
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What is the purpose of the st Answer: A modification has been made to an approved device in order to improve its performance?
| null |
What has been resolved based on experience with the approved device?
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safety and effectiveness
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What resolved initial questions of safety and effectiveness for the new patient population?
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Non-clinical and clinical data
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What may be appropriate to change the Category from A to B?
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If the device was previously designated as Category A, but the initial questions of safety and effectiveness of the device have since been resolved
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What is the name of the procedure that is used to place an already-approved or -cleared device?
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novel insertion procedure
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What is the second stage of a staged clinical study called?
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Category B
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What is needed to help inform a pivotal study design?
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Additional data
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What is the process of categorization of IDE devices?
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whether available data demonstrate that initial questions of safety and effectiveness have been resolved
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What is the categorization of IDE devices used by CMS?
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as part of its determination of which devices meet the requirements for Medicare coverage
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What is the name of the category decision Flowchart?
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Category Decision Flowchart
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What is the most difficult to duplicate in the laboratory setting?
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clinical environment in the laboratory
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What is the name of the docket that is listed in the notice of availability?
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HFA-305
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What is the name of the U.S. Department of Health and Human Services Office of Communication, Outreach and Development?
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CBER
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What is the name of the office that is responsible for the evaluation and research of biologics?
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Office of Communication, Outreach and Development Center for Biologics Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave., Bldg. 71, Room 3128 Silver Spring, MD 20993-0002
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What is the name of the center that studies radiological health?
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Center for Devices and Radiological Health
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When is OCP released?
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September 2023
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What is the name of the example of a PRESCRIPTION DRUG USE-RELATED SOFTWARE FUNCTIONS and END-USER OUTPUT?
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APPENDIX A
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What is the name of the document that contains nonbinding Recommendations Draft?
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Nonbinding Recommendations Draft
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What does not establish any rights for any person and is not binding on FDA or the public?
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It does not establish any rights
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What is the name of the center that is responsible for the development of the software outputs?
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Center for Biologics Evaluation and Research
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What is the name of the organization that created the guidance?
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Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), and the Office of Combination Products (OCP) at the Food and Drug Administration
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What is the FDA's guidance entitled?
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Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submi Answer: The Q-Submi Answer: The Q-Submi Answer: The Q-Submi Answer: The Q-Submi: The Q-Submi: The Q-Submi: The Q-Submi: The Q-Submi: The Q-Submi: The Q-Submi: The Q-Submi: The Q-Submi: The Q-Submi: The Q-Submi: The Q-Submi: The Q-Submi: The Q-Submi: The Q-Submi: The Q-Submi: The Q-Submi: The Q-Submi: The Q-Submi: The Q-Submi: The Q-Submi: The
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What does the term sponsor refer to?
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sponsors and applicants
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What is the primary mode of action of a drug?
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the drug provides the greater contribution to the intended therapeutic effects
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What is the term promotional labeling generally used to describe?
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any labeling other than FDA-required labeling
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What is the FDA's drug labeling authority called?
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Prescribing Information
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What does this guidance not apply to?
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software developers
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What does the FD&C Act define labeling as?
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all labels and other written, printed, or graphic matter
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What did the Court consider in evaluating whether materials “accompany” a product?
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whether the drug product and the materials related to the drug product were part of an integrated distribution program
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What does CDRH stand for?
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Center for 63 Devices and Radiological Health
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What does FD&C stand for?
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Federal Food, Drug, and Cosmetic Act
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What is another option for the clinical performance assessment of some CADe devices?
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A stress test
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What is the FDA anticipating a significant proportion of?
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prescription drug use-related software functions
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What is a function that is subject to FDA drug labeling authorities?
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some of these software 79 functions may meet the definition of a device11 as defined in the FD&C Act and would be 80 subject to device requirements
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What do guidances describe the Agency's current thinking on a topic?
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the Agency’s current thinking
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What is the CDRH Digital Health Center of Excellence?
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empower stakeholders to advance health care by fostering responsible and high-quality digital health innovation
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What does the term device not include?
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software functions
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What is the form FDA 2253?
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Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use
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What is one of the uses of software?
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assisting patients with tracking their own drug ingestion
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What does FDA intend to do when it comes to drug labeling?
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implement its policies and exercise its authorities, including drug labeling authorities
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What is the labeling that is reviewed and approved by FDA as part of an NDA, 115 ANDA, or BLA, as well as supplemental applications?
| null |
What must be truthful and non-misleading?
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Promotional labeling
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What will likely alter reader performance in the trial compared with clinical practice?
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the use of sample enrichment
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What is the postmarketing reporting requirement for submitting promotional materials to FDA?
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postmarketing reporting requirements
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What is a 132 output that supplements, explains, or is otherwise textually related to one or more of the 136 sponsor’s drug products?
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end-user 135 output
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What is one factor FDA intends to analyze when a sponsor 137 proposes to disseminate prescription drug use-related software for use with a drug or 138 combination product?
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whether the end-user 139 output should be treated as FDA-required labeling or promotional labeling and how, or if, the 140 corresponding software function should be described in the PI
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What is provided to support a clinical benefit when the prescription drug use-related software is used?
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evidence
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What is the software function18?
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prescription drug use-related software
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What rely on data directly19?
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device-connected software functions
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What does the guidance for industry and FDA staff describe?
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Multiple Function Device Products: Policy and Considerations
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What is the end-user output 167 of a software product considered to be?
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screen displays created by the software, whether static or dynamic, 168 as well as sounds or audio messages created by the software
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What should Sponsors provide to support how the combination product used with the software will not lead to medication errors?
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medication errors, such as inappropriate administration of extra doses
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What must the PI contain?
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a summary of the essential scientific information needed for the safe and Answer: The PI must contain a summary of the essential scientific information needed for the safe and Answer: Answer: The PI must contain a summary of the essential scientific information needed for the safe and Answer: Answer: The PI must contain a summary of the essential scientific information needed for the safe and Answer: The PI must contain a summary of the essential scientific information needed for the safe and Answer: The PI must contain a summary of the essential scientific information needed for the safe and Answer: The PI must contain a summary of the essential scientific information needed for the safe and Answer: The
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What is the design that can be “fully-crossed”?
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MRMC design
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What is the effective use of the drug product?
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190
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What is the name of the software that accompanies the proposed generic product?
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prescription drug use-related software
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What is the name of the section that describes the FD&C Act?
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section 505(j)(2)(A)(v)
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What is a nonbinding recommendation Draft?
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Not for Implementation 195 products
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What is the PI supposed to describe?
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device-connected software
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What should a sponsor provide that 207 demonstrate that use of the prescription drug use-related software results in?
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a meaningful 208 improvemen
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