Why does the FDA require testing multiple lots?

When device companies develop new products, there is usually a shortage of units available for testing. Often, the company will make just barely enough product to complete the testing requirements. However, many of the verification and validation testing protocols will require a minimum of three lots for testing.
For example, if you are validating the performance of an IVD assay that involves instrumentation, the FDA will require that you use at least three different instruments for your testing, and at least three lots of each raw material used in the assay should be evaluated to demonstrate consistency between lots.
Many clients ask us how to define a lot. To answer that question you need to understand why the FDA requires testing of multiple lots.
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How many different types of testing are required?

[@MedicalDeviceAcademy]

We created a test plan webinar to address this question specifically: medicaldeviceacademy.com/test-plan-webinar/
However, the general categories of testing are:
1. biocompatibility
2. sterilization
3. shelf-life
4. distribution
5. reprocessing
6. software
7. cybersecurity
8. wireless coexistence
9. interoperability
10. EMC
11. electrical safety
12. non-clinical performance
13. human factors
14. animal studies
15. human clinical studies