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What may disapprove an IDE application if there is reason to believe that the risks to the subjects outweigh the anticipated benefits to the subjects and the importance of the knowledge to be gained?
FDA may disapprove an IDE application if there is reason to believe that the risks to the subjects outweigh the anticipated benefits to the subjects and the importance of the knowledge to be gained.
What is the purpose of repeating important points and summarizing important information?
increase the reader’s recall and reading comprehension
What is the reading level of the medical device patient labeling?
eighth- grade level
What should be rewritten by applying the 23 principles of writing for increased comprehension?
patient labeling
What is holding a lighted match under a thermometer when you want to make your house warmer?
shortening words and sentences
What helps to find places where the medical device patient labeling may be inaccurate, incomprehensible, or poorly organized. User- oriented testing?
null
What are context clues?
words that surround a particular word or passage and can throw light on its meaning
What are the general principles of writing for increased comprehension?
Write with a specific type of person in mind. Stress the “need to know” information
Who will be using the device?
elderly, disabled, or children
What is one approach to provide a well-segmented, highlighted document with a table of contents and the most-desired, basic information up front?
provide one well-segmented, highlighted document
What is the intermediate form called?
a mini manual
What is the name of the Guidance for Industry and Food and Drug Administration Staff - Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications?
Guidance for Industry and Food and Drug Administration Staff - Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications
What is the term for a word that may affect the device and cause rust?
Dampness
What is the best way to store a device?
Always store the device in a dry area
What is the tolerance level of the gauge?
65 mm
What is the second person to personalize the material by using instead of the third person?
“he,” “she,” or “they.”
What is the better adverb?
green wire
What is necessary when operating the device?
Avoidance of cellular phones
What is the abbreviation for oxygen instead of O 2?
oxygen
What is the worst thing to do when using a device?
Look at the power cord for cuts or frays
What should you avoid in a sentence?
formal language
What do parentheses cause?
the reader to hesitate, making it hard to read
What does FDA staff determine about the probable benefits of the device?
whether the probable benefits of the device outweigh its probable risks
What should be the main idea of paragraphs?
a simple topic sentence
What should a reader do to avoid missing steps?
tell the reader how many steps are in the procedure
What do people most readily identify Arabic numbers with?
steps in a sequence
What is the better part of the procedure?
To turn the machine on: 1. Plug the power cord into an AC outlet
What is the purpose of cross referencing?
It is confusing to the reader
What is the speed by which letters and words can be recognized?
legibility
What is the most important part of a text heading?
capture the main points
What font allows more variation among letters than sans serif?
serif
What is the main purpose of using highlighting techniques?
to emphasize important words, thoughts, or phrases
What should be used between blocks of text to aid the ease of reading?
null
What should be used ragged right margins?
Use ragged right margins
What is a significant factor to consider?
neurological device
What is normally not appropriate and their use should be minimized in instruction manuals?
tables
What type of art makes the text more meaningful?
Illustrations
What do circles or arrows do to point out key information?
point out key information
What should be the title of a text?
Figure 1
What should be Eliminate 37 detail that is not necessary?
Captions
What should be included if a table or graph is necessary?
instructions on its use
What does this section discuss?
their use in medical device labeling
What is the least preferable method of controlling accidents and injuries?
Labeling
What does the term warnings and precautions present the reader with a cue to?
the seriousness of the hazard
What is the signal word for a hazard alert?
WARNING
What is an essential part of FDA's evaluation of devices targeting neurological disease progression?
Assessing probable benefits and probable risks
What is the target audience for medical device labeling?
target audience
What is the hierarchy of hazard alerts?
39
What must readers believe they can perform to avoid the hazard?
recommended response
What is the name of the symbol used to warn a reader of important hazard information?
CAUTION
What is the objective of this directive?
to give clear instructions to the user on how to avoid the hazard
What has shown that Hazard alert has a significant effect on readers?
Hazard alert research
What must a writer apply to write effective warnings and precautions?
principles discussed here
What may a home use device have warnings and precautions grouped according to?
Setup, Calibration, Use, Storage, and Disposal
What should warnings and precautions be in order of?
clinical significance
What do users more likely to read and comply with with warnings or precautions presented in outline form using plenty of?
plenty of white space and consistent indentations
What must the test dataset contain?
a sufficient number of cases from important cohorts
What provide potential participants adequate information to consider when deciding whether or not to participate?
Informed consent documents
What is the use of white space and simple high?
Conspicuous
What can increase consumer recognition?
Standardizing terms and formatting across the labeling
What is the reason for placing warnings and precautions in separate sections of medical device labeling?
user familiarity with this format
What is the most effective location relative to relevant text?
placement immediately before the associated procedural task
What is the most effective way to get readers to notice and read warnings and precautions?
testing draft warnings and precautions
What can have the same diluting effect as over-warning?
Careless designation
Why should you not rely on readability indexes to predict warning and precaution comprehension?
complexity of the process by which individuals interact
What is the most effective presentation for the intended audience?
labeling
What is the main method of pretesting the medical device labeling?
individual in-depth interviews, focus group interviews, self-administered questionnaires, usability testing, and readability testing
What helps to find places where the patient labeling may be inaccurate, incomprehensible, or poorly organized?
User-oriented testing
What does FD&C stand for?
Federal Food, Drug, and Cosmetic Act
Who guides the discussion?
a skilled moderator
What is an important sub-component of usability considerations for medical devices?
patient labeling
What is the purpose of usability testing?
the use of the device and its labeling materials by a group of intended users of the device
What can be used to assist the process of reviewing patient labeling?
Usability test results
What is the importance of a care regimen?
Importance of the need to adhere to a care regimen
What is the purpose of the guidance on the labeling of a medical device?
Writing for increased comprehension
What is the name of the publication that published the chapter 5 of Communicating Risks to the Public?
Kluwer Academic Publishers
What must an informed consent document for a neurological device targeting the progression of a disease describe?
the possibility that the proposed treatment may have little or no effect upon halting or delaying the progression of the disease, or could increase rate of progression
What is the labeling required to comply with?
21 CFR 812.5
What should your labeling alert users to?
potentiall
What is IDE?
Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions
When was the draft of the FDA/HCFA Interagency Agreement issued?
June 1, 2016
What is the name of the agency that regulates devices for Biologics Evaluation and Research?
Center for Biologics Evaluation and Research
What is the address of the Dockets Management Staff?
Food and Drug Administration
What is the name of the office that provides CBER guidance?
Office of Communication, Outreach, and Development
What are the recommendations that follow useful in demonstrating?
compliance with those special controls
What is the name of the document that contains nonbinding Recommendations?
2 Contains Nonbinding Recommendations Table of Contents I. Introduction . 4 II. Background . 5 III. FDA Interpretation of Medicare Coverage Categories A and B . 8 IV. Considerations When Changing from Category A to B .. 9 V. Examples ... 11 VI. Conclusions
What is IDE?
Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions
What does IDE stand for?
investigational device exemption
What did the FDA's Center for Devices and Radiological Health execute on December 2, 2015?
a Memorandum of Understanding
What did the MOU note the need for FDA and CMS to do?
revise their shared understanding
When did the MOU take effect?
June 2, 2016
What is the second category that FDA would assist CMS in identifying?
Non-experimental/Investigational (Category B) dev
What did the IA set forth that FDA would use to categorize devices?
criteria
What were devices believed to be in class III for which “absolute risk” of the device type had not yet been established?
Category A devices
What is a Category A device?
those devices for which no marketing application had been approved through the premarket approval (PMA) process for any indication for use
What is the purpose of the recommendations in this document?
guide you as you develop and test your CADe device
What was the name of the IDE Guidance Memorandum that was issued on Sept. 15, 1995?
#D95-2
What was the primary risk in question for devices believed to be in Class I or II?
incremental risk
What were Category B devices under investigation to demonstrate substantial equivalence to?
a predicate device
What is Category B?
Category A