Annex 1 [317 KB PDF] - Path

Needle-free intradermal delivery device questionnaire
Manufacturer information
Company name:
Address:
Contact person:
E-mail:
Website:
Name of intradermal delivery device:
Answer the following questions. Supporting documentation should be provided where possible. There is
no limit to the amount of text you may enter. Please also provide a copy of the Instructions for Use.
1. Provide the following summary of clinical and preclinical information related to device performance:
1.1. List vaccines delivered intradermally with the device.
1.2. List any pediatric use of the device and specify ages. Describe study results.
1.3. Describe the injection's effect on the skin (duration and type, e.g., wheal).
1.4. Describe the injected volume expressed as a percentage of intended dose.
1.5. Describe the volume delivered to the dermis expressed as a percentage of injected volume.
2. List any regulatory clearances, including approval date and indications for use. If clearances are either
planned or in process, please list the expected or actual date of submission.
3. Does the device comply with ISO 21649:2006?
3.1. Please specify which requirements have not been verified or those you anticipate will
not be met by your device.
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Needle-free intradermal delivery device questionnaire
4. Does the device comply with PQS E08/JI01.1?
4.1. Please specify which requirements have not been verified or those you anticipate will not
be met by your device.
5. What is the dose (or range of doses) the device is capable of delivering (ml)?
6. Describe the method of waste disposal for the consumables. What waste stream is appropriate for
consumables?
7. From what standard vial sizes is the device capable of drawing vaccines using the included
accessories? Can vaccine be drawn from an ampoule?
8. State the device's power source. If the device is manually primed, describe the mechanism and force
(N) required to do so.
9. What is the weight and size of the device (kg, length x width x height)? In addition, please list the
packaged weight and size of requisite accessory equipment (kg, length x width x height).
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Needle-free intradermal delivery device questionnaire
10. How much training (hours) is recommended for an operator to be able to use the device reliably?
Please state the minimum level of expertise expected that a trainee have prior to learning to use the
device.
11. Please list the environmental specifications for both device use and storage.
12. What is the expected lifetime of the device (number of injections)? What is the shelf life of the
consumables (years)?
13. How many dry fires can be reasonably expected without a degradation of performance?
14. Describe the cleaning protocol for the device.
15. What is the dead space of the syringe (μl)?
16. Is this device also capable of other depths of delivery? Please also list your other delivery devices and
their respective depths of delivery. For devices in development, please indicate expected date of
availability for clinical studies and regulatory clearance.
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