Question stringlengths 13 1.05k ⌀ | Answer stringlengths 2 801 ⌀ |
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What is the usefulness of predicting an expiration date from accelerated stability studies unclear? | because there is no validated accelerated testing method and because of the nature of adhesives and conductive gels |
What should also include information that demonstrates the role of accelerated stability testing in predicting the expiration date? | accelerated shelf-life testing |
What are the two main reasons for using reusable ECG electrodes? | potential for skin reactions and disease transmission |
What is the main benefit of disposable ECG electrodes? | they are intended |
What must an investigational plan also include in order to be considered? | a description of the device and its important components |
What is the name of the non-critical areas of the body that ECG electrodes are used on? | clean, intact skin |
What is the regulated under 21 CFR 882.1275? | Electroconductive media |
What must the electrode lead wires and patient cables be in compliance with? | test requirements and test methods |
What is the name of the document that describes ECG cables and leadwires? | ANSI/AAMI EC53 |
What must be MRI compliant, X-ray translucent, and MRI compliant before a medical device is introduced into interstate commerce? | 21 CFR Part 801 |
What does 801 Subpart C require for final labeling for an over the counter device? | labeling recommendations |
What should the intended use also identify? | the duration and application of use |
What should only be used by or in consultation with a health care provider familiar with their proper placement and use? | ECG electrodes |
What should be replaced if self-adhesive electrodes no longer stick firmly to the skin? | Self-adhesive electrodes |
What is the labeling for devices that contain natural rubber latex? | 21 CFR 801.437 |
What should be included in each planned clinical study? | a detailed description of the initial feasibility study (i.e., study to define clinical metrics or device design) |
What specifies the limitations to exemption? | Section 21 CFR 870.9 |
When was the Draft Guidance on Medical Device Patient Labeling issued? | March 3, 2000 |
What is the name of the room that is used to submit comments to the agency? | Room 1061 |
Where can you obtain additional copies of guidance? | the Internet |
What are the general types of information that may be included in medical device patient labeling? | types of information that may be included in medical device patient labeling |
What is the purpose of Appendix D? | Appearance of graphics: ..35 Appendix D Warnings and precautions: 39 Appendix F Pretesting: 44 Checklist Summary: ..46 References: Answer: 46 References: Answer: 44 References: Answer: 44 References: Answer: 44 References: Answer: 44 References: Answer: ..46 References: Answer: ..46 References: Answer: ..46 References: Answer: ..46 References: Answer: ..46 References: Answer: ..46 References: Answer: ..46 References: Answer: ..46 References: Answer: ..46 References: Answer: ..46 References: Answer: ..46 References: Answer: ..46 References: Answer: ..46 References: Answer: |
What is the total time planned for subject follow-up? | time planned for subject follow-up |
What does not create or confer any rights for or on any person? | any rights |
What is the purpose of this guidance? | to assist manufacturers in their development |
What does Device labeling evolve throughout? | the review process |
What is the name of the format in which medical device patient labeling is supplied? | pat |
What is the purpose of medical device patient labeling? | may accompany devices intended solely for physicians to operate, devices for both physicians and patients or lay caregivers to operate, and devices operated solely by patients or their lay caregivers |
What does patient labeling inform patients or their lay caregivers about? | proper use, risks, and benefits of the device |
What is needed to make devices safe and effective? | Adequate directions for operating the devices |
What is the term for information that allows the users to become aware of potential problems with the device? | Risk/benefit information |
What is the main risk to the patient associated with using a device? | environment |
What is the “how to” for a device? | Instructions for Use |
What are the primary safety and effectiveness endpoints described as? | specific objective clinical targets |
What is the name of the device that is used to physical therapy equipment? | transdermal electrical nerve stimulation (TENS) devices |
What type of users are more likely to use the device as you intend? | Knowledgeable |
What is a risk/benefit information situation? | instructions for use |
What should lay caregivers need to do to explain the operation of the device to others? | explain the operation of the device |
What should lay caregivers or others need to understand to use a device? | requirements of care or the alterations of lifestyle associated with care |
What are some examples of ways that patients or lay caregivers can cooperate with the prevention, treatment, or diagnosis of an illness? | bone density scan, drugs of abuse test kits |
What is a tool of the health care practitioner and the patient is not involved in the choice of the device? | The device is a tool of the health care practitioner and the patient has no control over or access to the device |
What is a patient's opportunity to benefit from patient labeling outweighed by the risk of allowing him the opportunity in an emergency? | the risk |
What is the patient's right to know, choose, and decide subordinated to? | obligation to give prudent care |
What is the minimum time a health professional or supplier must pass along the patient labeling? | Must an intermediary, such as a health professional or a supplier, pass along the patient labeling or can it be provided directly to the patient |
What are medical image analyzers required to comply with under 21 CFR 892.2070? | special controls |
What is the primary safety endpoint? | primary |
What can you do to help patients get the most up-to-date information? | place patient labeling there |
What is the name of the document that FDA released that detailed the requirements for patient labeling? | Draft Report on Medical Device Labeling: Patients’ and Lay Caregivers |
What is grouped together? | similar information |
What might not apply to all medical device labeling? | headings related to instructions for use |
What is a good place to place a glossary if the medical device labeling is lengthy and complex? | after the table of contents |
What is the purpose of the device? | Briefly describe the FDA cleared or approved indications for use |
What are conditions under which a device should not be used because the risk of use clearly outweighs any possible benefit? | Contraindications |
What are known and reasonably foreseeable hazards? | List known and reasonably foreseeable hazards, not theoretical possibilities |
What is the risk of being harmed because of patient characteristics? | substantial risk |
What is the goal of risk/benefit information as applied to medical device patient labeling? | to provide the patient with information about the risks and benefits associated with a device or procedure in a manner that is meaningful to the user |
What should be clearly delineated in the study protocol? | reporting and adjudicating adverse events |
What should people's concerns about their personal risk be addressed? | Anticipate and respond to people’s concerns |
What can be done to overcome risk? | take the silicone sheet off for a few days, then start again |
What can help to ensure more accurate interpretation of risk information? | Combining visuals with brief text that contains the “take-home” message |
What should the content of risk messages reflect? | the perspective, technical capacity, and concerns of the target audience |
What does “risk” raise? | alarm |
What should be limited to when making comparisons? | risks that are similar or closely related |
What is the purpose of nalogies? | • may discuss the nature of the risk. • may include alternatives. • may discuss benefits. |
What is the attitude toward the risks and benefits? | What is the attitude toward the risks and benefits |
What is Embedded in the concept of risk/benefit information? | the type of in Appendix E |
What is the specific hazard alert information that a user needs to know before using the device? | general warnings and precautions |
What should the benefit-risk framework focus on? | device technology |
What do warnings and precautions tell the reader about? | hazards, other than those |
What provides information on how to avoid hazards? | Warnings and precautions |
What can that approach lead to? | information overload |
What is the eighth grade reading level? | ps |
What is the name of the step that should be followed for setup? | table top or floor |
What is a good example of a checkout procedure? | visual inspection of the device |
When should the checkout be done? | at the time of setup and/or before each use |
What should the user place immediately before the corresponding task or instruction? | any warnings or safety instructions |
What does the section in the medical device patient labeling explain to the user? | the importance of monitoring the activity of the device |
What is the name of the device that is used to clean? | device |
What is the only subset of the eligible study subject population allowed to accept? | the risks as weighed against the benefits |
What should the user briefly outline to help them with maintenance? | proper maintenance actions, who is responsible, and how often the action should be done |
What should the user do if extended storage may affect the device? | inform the user |
What is the expected failure time and mode and its effect on the patient? | State how long the device will last |
What is an example of a device that can be safely disposed of? | mercury containing devices |
What is the purpose of the additional device? | impacts the safe and effect |
What does troubleshooting help determine when a problem occurs? | if the problem is with the device or with the patient’s condition |
What is the name of the section that highlights each group heading? | Highlighting |
What should users do if their device displays error messages? | list them and what they mean |
What is the name of the section that tells the user how to report undesirable outcomes? | adverse events |
What do we refer to the categories of information that not all patients want in medical device labeling? | additional information |
What are some patients more risk averse? | some patients |
What is the most common way to have additional information available on demand? | most prefer to see it at the end of the document or have it available on demand |
What type of information should a patient have to have to be written in? | simple, plain language |
What may have adverse event data from other sources? | Other devices may have adverse event data from other sources, e.g., published literature or experience with similar devices |
What is the name of the section that contains potentially fatal adverse events? | Contraindications section |
What is the name of the device that a patient can use to list their implant? | card or sticker |
What is the name of the converter that may need to convert to the proper voltage? | converter |
What does the FDA recommend for all other devices? | labeling |
What can include a toll-free number or the number for customer assistance? | medical device patient labeling |
What is readability defined as? | the style of writing |
What is the quantitative factor used to assess readability? | results of readability formulas |
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