WuXi AppTec has over 25 years’ industry experience, and the track record to ensure your successful combination product regulatory submission. Our technical experts have experience with CDRH, CEBR and CEDR, and will create a test plan customized to meet your product needs through an approach preferred by regulators.
To improve your submission success, WuXi AppTec recommends a risk-based approach to product evaluation.
Submissions would include a complete biological evaluation. A risk assessment and analytical chemistry extractables/leachables testing will identify potential hazardous chemicals and through a risk assessment, evaluate the toxicity. This is consistent with the risk-based emphasis of ISO 10993, and the 2016 FDA Guidance on Use of ISO 10993.
Second, to mitigate risks identified in the risk assessment and/or to address local endpoints, a biocompatibility panel would be recommended custom to your product and its indication(s). A final biological evaluation should include a weight-of-evidence and discussion that captures the chemical characterization, risk assessment, and biocompatibility test results.
- Treat the combination product as a new product for submission. Off-the-shelf or predicate devices with existing approvals may be incomplete within the new product design.
- Items that are packaged separately and cross-labelled for use together are considered combination products.
- When preparing a biological test plan, use the results of chemical characterization and the risk assessment to select the appropriate biological tests to mitigate risks.
- Working with WuXi AppTec will ensure the biological evaluation is written to current versions of all regulatory guidance and standards.
Here are some additional references on combination products:
A newsletter published by the SOT Medical Device and Combination Product Specialty Section (MDCPSS) in Summer 2015:
A 2016 special report published by Medical Alley: