Please take a few minutes to complete this questionnaire and return it to the designated box on the registration table. The feedback that you provide will help us better understand how we can make the labeling repository more accessible and easy to use.
The following definitions of medical device “labeling” and “label” should be used:
The term "labeling" means all labels and other written, printed, or graphic matters upon any medical device or any of its containers or wrappers, or accompanying such medical device.
The term "label" means a display of written, printed, or graphic matter upon the immediate container.
- Medical devices may be available for use for years after distribution by the original manufacturer. Some, but not all, device labeling can be found on the original manufacturer’s website. Would it be helpful for you to have one place to look on the web that has product instructions for all devices, both new and old?
- Yes, please explain:
- No, please explain:
- Yes, please explain:
- How frequently do you use the labeling that comes with a medical device (i.e., instructions for use, warnings and precautions, safety information, etc.)? (Select all that apply)
- Every time I use the device
- When I first receive the device
- When I cannot figure out how to use the device
- When I have a problem using the device
- When I am cleaning or maintaining the device
- When I want to understand the risks of the device
- Other, please specify:
- If you do not use the device labeling, is it because (select all that apply)
- The instructions for use are not available
- The instructions for use are not complete
- The instructions for use are difficult to understand or follow
- There is too much information to understand
- I am familiar with the specific device, so I don’t need to use the labeling.
- I am familiar with similar devices, so I don’t need to use the labeling.
- I don’t think that I need them
- Other, please specify:_____________________________________________
- Do you use instructions for use if you need to teach someone how to use the device?
- Yes, I use what is supplied with the device
- Sometimes. Please specify:
Some portions. Please specify:
- It usually isn’t available
- I develop my own instructions for teaching
- Not applicable
- If you use instructions for use that come with the device to teach someone, do you use patient instructions or health care practitioner instructions?
- Patient instructions
- Health care practitioner instructions
- There is only one type of instructions for use and it does not specify who it is intended for
- There were no product instructions for use that came with the device
- Both the patient and health care practitioner instructions
- When you use device instructions, what are the most important pieces of information to you? (e.g., manufacturer contact information, service hotline number, photos of the device, photos of the device in use, accessories, cleaning instructions, maintenance instructions, calibration, set up, warnings and contradictions for use, instructions for use). List all that apply:
- How would you prefer to access online labeling information? (Select all that apply)
- On a searchable and publicly accessible online database that holds all labeling
- On a searchable and publicly accessible online database that has links to all labeling on manufacturers’ websites
- On an individual manufacturer’s website where they provide or link to their labeling
- On a mobile application or similar tool
- Online labeling access isn’t important to me
- I do not access labeling online
- Labeling isn’t important to me
- If FDA were to require package inserts in a labeling regulation, what would you consider to be part of this? (Select all that apply)
- Additional information about the device including photographs and accessories
- Explicit instructions for use including warnings, precautions, and cleaning
- Information for safe use
- Patient highlight section
- Intended use
- Other, please specify: _______________________________________________________
- If you could search on labeling in a database, what would you want to search on? (Select all that apply)
- Search by manufacturer name and information
- Search by device name
- Search by device model number
- Search by device type (e.g., electric wheelchair, injection syringe, glucometer)
- Search for similar devices across a product line
- Device materials that may cause a allergic reaction
- MRI compatibility
- Adverse reactions
- Warnings and precautions
- Indications and Contraindications
- Other, please specify: ________________________________________________________
- Do you think it is necessary for medical devices to have separate labeling that is written for patients, caregivers or consumers? (Select all that apply)
- Yes, always, for every device
- Yes, for over-the-counter devices
- Yes, for devices that are used or operated by patients/caregivers/consumers
- Yes, for implanted devices
- Yes, for other:
- Why or why not?
- If you are considering using a new medical device that you have never used before, where would you go to find information about its risks and benefits?
- Where would you go to find the instructions for use?
- Is it important for you to see a photograph of the device? (Select all that apply)
- Yes, and more than one if I need to see all sides of it
- Yes, and the components too
- Yes, and the device in use
- No, it isn’t important to me
- What would be a reason to see a photograph of the device?
- If you had an older device that was no longer being distributed, where would you go to find the labeling if you needed it?
- Are there any other comments you would like to share with FDA about how you use labeling or how labeling could be improved?