Labeling Repository for Medical Devices - Industry 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.
- 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:
- When you use device instructions, what are the most important pieces of information to you? (e.g., 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 on-line labeling information? (Select all that apply)
- On a searchable and accessible database that holds all labeling
- On a searchable and publicly accessible online database that has links to all labeling on manufacturers’ websites
- On a manufacturer’s website where they provide or link to their labeling
- On a mobile application or similar tool
- How does your firm provide labeling? (Select all that apply)
- With distributed medical devices
- Through medical representatives
- Through promotional materials, including print advertising
- Through medical information request services
- On the manufacturer’s webpage
- On the distributor’s webpage
- On a product specific webpage
- On a company webpage oriented to consumers
- On a company webpage restricted to health care professionals
- 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 a database of labeling, 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?
- 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
- How do you distribute updated labeling to your users?
- I don’t
- I do, directly to the user
- I do, through the distributor directly to the user
- I do, through the manufacturer representative
- I do, through my websites
- Other: ______________________________________________________
- What are the benefits of posting labeling on a government website?
- What issues would need to be resolved in order for this to work?
- Are there any other comments you would like to share with FDA about how you use labeling or how labeling could be improved?