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Medical Devices

Labeling Repository for Medical Devices - Consumer Questionnaire

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.

Think about a specific device you use (name of device) and consider this device when answering some of the questions below:

  1. 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?
    1. Yes, please explain:
    2. No, please explain:
  2. 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)
    1. Every time I use the device
    2. When I first receive the device
    3. When I cannot figure out how to use the device
    4. When I have a problem using the device
    5. When I am cleaning or maintaining the device
    6. When I want to understand the risks of the device
    7. Never
    8. Other, please specify:
  3. If you do not use the device labeling, is it because (Select all that apply)
    1. The labeling is not available
    2. The labeling is not complete
    3. The labeling is difficult to understand or follow
    4. There is too much information to understand
    5. I am familiar with the specific device, so I don’t need to use the labeling.
    6. I am familiar with similar devices, so I don’t need to use the labeling.
    7. Other, please specify:____________________________________________
  4. When you use device labeling, 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:
    1. __________________________________________________________
    2. __________________________________________________________
    3. __________________________________________________________
    4. __________________________________________________________
    5. __________________________________________________________
    6. __________________________________________________________
    7. __________________________________________________________
  5. How would you prefer to access online labeling information? (Select all that apply)
    1. On a searchable and publicly accessible online database that holds all labeling
    2. On a searchable and publicly accessible online database that has links to all labeling on manufacturers’ websites
    3. On an individual manufacturer’s website where they provide or link to their labeling
    4. On a mobile application or similar tool
    5. Online labeling access isn’t important to me
    6. I do not access labeling online
    7. Other:_____________________________________________________
  6. If FDA were to require package inserts in a labeling regulation, what would you consider to be part of this? (Select all that apply)
    1. Additional information about the device including photographs and accessories
    2. Explicit instructions for use including warnings, precautions, and cleaning
    3. Information for safe use
    4. Patient highlight section
    5. Intended use
    6. Other, please specify:
  7. If you could search on a database of labeling, what would you want to search on? (Select all that apply)
    1. Search by manufacturer name and information
    2. Search by device name
    3. Search by device model number
    4. Search by device type (e.g., electric wheelchair, injection syringe, glucometer)
    5. Search for similar devices across a product line
    6. Device materials that may cause a allergic reaction
    7. MRI compatibility
    8. Adverse reactions
    9. Recalls
    10. Warnings and precautions
    11. Indications and Contraindications
    12. Other, please specify:
  8. Do you think it is necessary for medical devices to have separate labeling that is specifically written for patients, caregivers or consumers? (Select all that apply)
    1. Yes, always, for every device
    2. Yes, for over-the-counter devices
    3. Yes, for devices that are used or operated by patients/caregivers/consumers
    4. Yes, for implanted devices
    5. Yes, for other:
    6. No
    7. Why or why not?
  9. 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?
  10. Where would you go to find the instructions for use?
  11. When selecting a new medical device, is it important for you to see a photograph of the device? (Select all that apply)
    1. Yes, and more than one if I need to see all sides of it
    2. Yes, and the components too
    3. No, it isn’t important to me
    4. Why or why not?
  12. If you had an older device that was no longer being distributed, where would you go to find the labeling?
  13. Are there any other comments you would like to share with FDA about how you use labeling or how labeling could be improved?

Page Last Updated: 02/12/2015
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