About the Author
Proxima CRO Team
Isabella Schmitt, MBA, RAC
Director of Regulatory Affairs
Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications.

Bench testing will contain the majority of design verification and validation testing. It should be included in the final submission if bench test results are used to support substantial equivalence.

Animal testing is not obligatory but can be used to support substantial equivalence. The submission should include:

  • Specific animal tests
  • Description of test protocol: objective of the test, test articles used, test methods and procedures, study endpoint, specific parameter measured, pre-defined acceptance or pass/fail criteria
  • Summary of results
  • Analysis and conclusions

Clinical testing is also not obligatory, and FDA will consider alternatives to clinical studies given that those proposed alternatives are supported by adequate scientific rationale. The submission should include:

  • Objective of the test
  • Test methods and procedures (including any specific test conditions)
  • Study endpoints (safety and effectiveness)
  • Statistical methodology used

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