WuXi AppTec • 2540 Executive Dr. • St. Paul, MN 55120 | 651.675.2000 • 888.794.0077 | us.wuxiapptec.com
Please complete this form with as much information as you are able to provide, adding any additional notes/comments that will help us better understand your product and this project. If you have any questions, please contact your Account Manager.
PROPRIETARY AND CONFIDENTIAL
Be assured that WuXi AppTec will hold all information at the highest level of confidentiality. Likewise, this form is considered proprietary and confidential and is to be used solely for the purpose of submission to WuXi AppTec.
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/ DEVICE / MATERIAL PROFILE FORMDATE:
1.0 CLIENT INFORMATION All of these fields are required.
Company Name and Address:
Primary Contact Name:
Primary Contact Title:
Telephone Number:
Email:
2.0 PROJECT-SPECIFIC INFORMATION
2.1 / What is the purpose of your request? Check all that apply: / Research and Development
Biocompatibility Test Plan
Regulatory Submission or Regulatory Approval for Next-Generation Device. Check all that apply:
FDA EU Japan China Korea Australia Other:
Device Change (e.g. material, manufacturing, sterilization, vendor, etc.). Describe:
Failure Analysis. Describe:
Regulatory Response. Provide regulatory question(s):
Biocompatibility Test Failure. Describe:
Test Article Extraction Issue (e.g. degradation, particulates, color change, etc.) Describe:
Specific Concerns. Describe:
Other (describe):
3.0 DEVICE or MATERIAL INFORMATION All of these fields are required.
(Provide information EXACTLY as it is to be described in the report.) /
3.1 / Name of device or material:
3.2 / Indications for use:
3.3 / Device background: (include a description of how the device is intended to be used in patients)
3.4 / Type of body contact: / Select from dropdownSurface: Skin (Intact)Surface: Mucosal MembraneSurface: Breached or CompromisedExternal Communicating: Blood Path, IndirectExternal Communicating: Tissue/Bone/DentinExternal Communicating: Circulating Blood, DirectImplant: Tissue/BoneImplant: Blood
3.5 / Duration of patient contact: / Select from dropdownLimited (≤ 24 hours)Prolonged (>24 hours to ≤30 days)Permanent (>30 days)
Approx. # of days/hours in contact:
Explain the maximum duration of device exposure and/or if the device consists of multiple components with various exposure durations:
3.6 / What is the pattern of clinical use (used only once, daily, weekly, etc.):
3.7 / Specify the materials or constituents in the device, including colorants and additives (CAS Numbers and MSDS, if available) or provide a on a separate attachment (e.g., B.O.M.)
NOTE: It is recognized that this information may be proprietary and not available / NA Unknown
3.8 / Provide dimensions of a single device or provide a diagram with dimensions on a separate attachment.
3.9 / Specify device thickness:
NOTE: The extraction ratio will depend on the wall thickness of the thinnest portion/component of the device. / <0.5mm >0.5mm NA
3.10 / Total surface area, weight and/or fluid path volume of a single device:
NOTE: Per ISO 10993-12, a surface area ratio should be used whenever possible rather than a weight ratio.
3.11 / Maximum surface area and/or weight in direct or indirect patient contact:
3.12 / Can the device be cut?
NOTE: The device should not be cut if there are materials inside the device that should not be exposed for testing.
Comments: / Yes No
3.13 / Maximum number of devices or material per patient:
3.14 / Target population for device: / Adult Men Adult Women Pregnant women
Children Neonate Other:
3.15 / Is your device a final (i.e., sterilized) finished product? / Yes No
If no, explain:
3.16 / Sterilization Method: / EO Radiation E-Beam
Other:
3.17 / Is your device currently approved? / Yes No NA
If yes, indicate agency(s) by checking all that apply: / FDA EU Japan China
Korea Australia
Other:
NOTE: Provide a photo and diagram with dimensions in a separate attachment to your email when returning the completed questionnaire.
4.0 ANALYTICAL CHEMISTRY TESTING (if applicable): /
4.1 / Anticipated Chemistry Testing (check all that apply): / Material Characterization / Material ID
Extractables Testing
Leachables Testing
Targeted Analysis, Specify Target(s):
Vendor or Process Change
Lot Release / Monitoring
Package Testing
Other:
4.2 / Is this request a repeat of an earlier WuXi AppTec project with the same or a similar device? / No
Yes, WuXi AppTec Project or “D” number(s):
Repeat the analytical conditions used previously
Use the following conditions:
Conditions unknown (TBD)
4.3 / Do you require the testing to be performed GLP?
Note: Conducting GLP is not a regulatory requirement for chemistry testing. / Yes No Not Sure
5.0 CONSULTING SERVICES (if applicable) /
5.1 / Consulting Service (check all that apply): / Toxicological Risk Assessment. Choose one:
Assess the safety of the extractable and/or leachable chemicals from device/material.
Assess the safety of the extractable and/or leachable chemicals from device/material and include the biocompatibility test results for a full Biological Evaluation.
Toxicological material assessment (qualitative assessment for test plan development; note: not fully compliant with regulatory requirements)
Gap analysis to identify and access impact against current standards. Provide WuXi AppTec project or “D” number(s) or copy of reports:
Biological evaluation testing strategy (a formal, submission ready document outlining a testing program)
Other (describe):
6.0 ADDITIONAL COMMENTS /
6.1 / Special requirements and/or comments:
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