Animal Testing for 510k Document Submission

Animal Testing for 510k Document Submission

 

The animal studies utilized for the assessment of the devices initial evidence of device safety, their potential performance when used in a living system, and the biologic response that a living system may mount towards the device.

 

If the clinical testing is required, then the selection criteria of particular animal models for your animal study is given below.

  • if your study is significant or non-significant risk
  • completion of bench testing
  • Is there an established animal model for the type of device you are testing?
  • Approval of a similar device for the same indications for use?
  • Is there new indications that suggest the use of different or additional evaluation time points or methods?
  • Is there anything known about the device that would indicate high variability of animal responses?

If, after consideration of all these issues, you would like FDA feedback on your proposed animal study strategy, FDA recommends that you submit a Pre-IDE that includes a proposal for your pivotal GLP animal studies.