Here’s what you should know:
1. Through the new program, developers can submit a tool for consideration. The FDA can decide whether to “qualify” it. FDA qualification means a device functions as described and does so accurately.
2. The FDA announced it would only qualify tools if there’s a high level of publically available information, so the device development community will have an understanding of the device’s potential benefits beforehand.
3. The FDA believes qualified tools speed up medical device development by reducing reliance on animal testing as well as minimizing test duration or necessary sample size.
4. The FDA is offering the qualification for three types of tools:
- Clinical outcome assessment tools
- Biomarker tests
- Nonclinical assessment models
For more information on the qualification process, click here.
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