Question stringlengths 13 1.05k ⌀ | Answer stringlengths 2 801 ⌀ |
|---|---|
What is the FDA unsure of? | whether the device type can be safe and effective |
What is a factor in evaluating whether or not an IDE device receives Medicare coverage? | CMS uses FDA’s categorization determination |
What is the criteria for a Category A device? | 42 CFR 405.212 |
What does 42 CFR 405.211(b) do? | Contains Nonbinding Recommendations Category A (Experimental) IDE study, but not the device itself |
What is the name of the document that provides guidance on the development and review of IDE applications for early feasibility studies? | IDEs |
What are feasibility studies intended to provide? | proof of principle and initial clinical study data |
What is the most common submission type for CADe devices addressed in this guidance? | A 510(k) submission |
What are clinical investigations designed to collect definitive evidence of the safety and effectiveness of a device for a specified intended use? | Pivotal studies |
What is the category designation based on? | the criteria described in this document |
What did the IA not describe? | a pathway for chang |
What did CMS change in January of 2015? | 42 CFR 405.211(a) |
What did CMS and FDA need to revisit to ensure reimbursement of devices will not be precluded due to an inappropriate reimbursement categorization determination? | their shared understanding |
What is the definition of an IDE application? | approved with conditions |
What is the FDA unsure if the device type can be safe and effective? | whether the device type can be safe and effective |
What is being studied for a new indication? | The proposed device |
What is the FDA Guidance document called? | FDA Decisions for Investigational Device Exemption Clinical Investigations |
What does the FD&C Act stand for? | Food, Drug, and Cosmetic Act |
What does the proposed device have different compared to a legally marketed device? | technological characteristics |
What is the primary risk in question for a device? | the incremental risk |
What resolves the initial questions of safety and effectiveness? | available information (e.g., feasibility study data) from the proposed device or a similar device |
What may also have been used to resolve these questions? | additional non-clinical and/or clinical data |
What can come from different sources and become available at different points in time? | Data |
What is the name of the stage of a clinical study on the investigational device? | a stage of a clinical study |
What may be warranted when an IDE study receives a staged approval? | category change |
What may resolve initial questions of safety and effectiveness? | data gathered from the first (or subsequent) enrollment stage(s) |
What is a categorization decision made upon study approval? | a new study |
What should the supplement include that would support meeting the criteria as identified in 42 CFR 405.201(b)? | data which would support a change from Category A to Category B |
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? | 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 |
What is included as supportive information? | Additional non-clinical data on the same or a similar device |
What may also change from B to A? | category designation |
What is the name of the document that the sponsor must send to CMS to determine the categorization decision? | IDE (original or supplement) approval letter |
What is the definition of Category A? | completely novel and has no, or limited, previous human use |
What is not available to address the initial questions of safety and effectiveness associated with the addition of the drug? | relevant non-clinical or clinical data |
What is the device’s technology unchanged from? | what was initially approved or cleared |
What is the initial question that FDA is unsure whether or not the device type can be safe and effective? | effectiveness |
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? | initial questions of safety and effectiveness related to this change |
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? | A new device |
What is the name of the FDA's room 1061? | HFA-305 |
What should be used to preclude or limit biases that might impact conclusions? | well-controlled study design |
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? | safety and effectiveness |
What resolved initial questions of safety and effectiveness for the new patient population? | Non-clinical and clinical data |
What may be appropriate to change the Category from A to B? | If the device was previously designated as Category A, but the initial questions of safety and effectiveness of the device have since been resolved |
What is the name of the procedure that is used to place an already-approved or -cleared device? | novel insertion procedure |
What is the second stage of a staged clinical study called? | Category B |
What is needed to help inform a pivotal study design? | Additional data |
What is the process of categorization of IDE devices? | whether available data demonstrate that initial questions of safety and effectiveness have been resolved |
What is the categorization of IDE devices used by CMS? | as part of its determination of which devices meet the requirements for Medicare coverage |
What is the name of the category decision Flowchart? | Category Decision Flowchart |
What is the most difficult to duplicate in the laboratory setting? | clinical environment in the laboratory |
What is the name of the docket that is listed in the notice of availability? | HFA-305 |
What is the name of the U.S. Department of Health and Human Services Office of Communication, Outreach and Development? | CBER |
What is the name of the office that is responsible for the evaluation and research of biologics? | 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 |
What is the name of the center that studies radiological health? | Center for Devices and Radiological Health |
When is OCP released? | September 2023 |
What is the name of the example of a PRESCRIPTION DRUG USE-RELATED SOFTWARE FUNCTIONS and END-USER OUTPUT? | APPENDIX A |
What is the name of the document that contains nonbinding Recommendations Draft? | Nonbinding Recommendations Draft |
What does not establish any rights for any person and is not binding on FDA or the public? | It does not establish any rights |
What is the name of the center that is responsible for the development of the software outputs? | Center for Biologics Evaluation and Research |
What is the name of the organization that created the guidance? | 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 |
What is the FDA's guidance entitled? | 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 |
What does the term sponsor refer to? | sponsors and applicants |
What is the primary mode of action of a drug? | the drug provides the greater contribution to the intended therapeutic effects |
What is the term promotional labeling generally used to describe? | any labeling other than FDA-required labeling |
What is the FDA's drug labeling authority called? | Prescribing Information |
What does this guidance not apply to? | software developers |
What does the FD&C Act define labeling as? | all labels and other written, printed, or graphic matter |
What did the Court consider in evaluating whether materials “accompany” a product? | whether the drug product and the materials related to the drug product were part of an integrated distribution program |
What does CDRH stand for? | Center for 63 Devices and Radiological Health |
What does FD&C stand for? | Federal Food, Drug, and Cosmetic Act |
What is another option for the clinical performance assessment of some CADe devices? | A stress test |
What is the FDA anticipating a significant proportion of? | prescription drug use-related software functions |
What is a function that is subject to FDA drug labeling authorities? | 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 |
What do guidances describe the Agency's current thinking on a topic? | the Agency’s current thinking |
What is the CDRH Digital Health Center of Excellence? | empower stakeholders to advance health care by fostering responsible and high-quality digital health innovation |
What does the term device not include? | software functions |
What is the form FDA 2253? | Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use |
What is one of the uses of software? | assisting patients with tracking their own drug ingestion |
What does FDA intend to do when it comes to drug labeling? | implement its policies and exercise its authorities, including drug labeling authorities |
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? | Promotional labeling |
What will likely alter reader performance in the trial compared with clinical practice? | the use of sample enrichment |
What is the postmarketing reporting requirement for submitting promotional materials to FDA? | postmarketing reporting requirements |
What is a 132 output that supplements, explains, or is otherwise textually related to one or more of the 136 sponsor’s drug products? | end-user 135 output |
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? | 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 |
What is provided to support a clinical benefit when the prescription drug use-related software is used? | evidence |
What is the software function18? | prescription drug use-related software |
What rely on data directly19? | device-connected software functions |
What does the guidance for industry and FDA staff describe? | Multiple Function Device Products: Policy and Considerations |
What is the end-user output 167 of a software product considered to be? | screen displays created by the software, whether static or dynamic, 168 as well as sounds or audio messages created by the software |
What should Sponsors provide to support how the combination product used with the software will not lead to medication errors? | medication errors, such as inappropriate administration of extra doses |
What must the PI 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: 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 |
What is the design that can be “fully-crossed”? | MRMC design |
What is the effective use of the drug product? | 190 |
What is the name of the software that accompanies the proposed generic product? | prescription drug use-related software |
What is the name of the section that describes the FD&C Act? | section 505(j)(2)(A)(v) |
What is a nonbinding recommendation Draft? | Not for Implementation 195 products |
What is the PI supposed to describe? | device-connected software |
What should a sponsor provide that 207 demonstrate that use of the prescription drug use-related software results in? | a meaningful 208 improvemen |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.