Medical Device Development Tool (MDDT) Qualification
The US FDA has provided guidance on the methods and approaches to qualify a medical device development tool so that medical device manufacturers or sponsors can use them to support the development and evaluation of medical devices. The manufacturer is expected to ensure the tool produces “scientifically-plausible measurements” and works as intended within the specified intended use of the tool. Some specific points in the guidance for medical device development tool qualification are:
- Specification of the intended use and the scope of the product areas covered
- What the medical device development tool measures or produces as an output
- Role of the medical device development tool with respect to clinical uses or study parameters
- Phases of the medical device development lifecycle where the medical device development tool will be used
Read more about the medical device development tool qualification program at this link: https://www.fda.gov/MedicalDevices/ScienceandResearch/MedicalDeviceDevelopmentToolsMDDT/ucm20041609.htm
This is generally for tools related to evaluation of clinical performance. The final guidance for the MDDT was issued August 10, 2017 and can be viewed and downloaded here: FDA Final Guidance on MDDT-2017.
If you are new to validation of tools and software not actually in the medical device, see our Post on validation of these types of software: Production and Process Validation
