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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