Qualification of Development Tools for Medical Devices - Guidance for Industry

The topic of development has been playing an important role for the FDA, not only in the pharmaceutical sector, but also with regard to medical devices for quite some time. For that reason the authority issued a draft guideline describing the qualification of development tools for medical products in 2013 already. The topic of development of medical devices is also embedded in an FDA initiative, which is supposed to lead to a faster approval of medical devices. However, the programme runs on a voluntary basis.

The draft of this guideline has now been finalized: Qualification of Medical Device Development Tools (MDDT). This guideline comprises 24 pages. Qualification in this context means that the FDA has evaluated the tool to be used during development and that is has provided scientifically sound results. If a tool is then published (the programme is voluntary), clinical study sponsors can use it for the purposes it has been qualified for. According to the guideline an MDDT is a method, a material or a measurement used to evaluate the effectiveness, safety or performance of a medical device.

The FDA classifies the tools in three categories

  • Clinical outcome assessment (e.g. the NIH stroke scale) 
  • Biomarker test (e.g. for the determination of blood values) 
  • Nonclinical assessment model (e.g. via computer models)

In the guideline the qualification process for such a tool is then explained as a 4-phase process (starting with a proposal phase up to the actual qualification phase). A change control stage after the successful qualification is also part of the process, quasi as phase 5.

In a 2-pages appendix the guideline comprises an overview about what a qualification package for a tool could look like.

The slides of a webinar with the title CDRH Final Guidance: Qualification of Medical Devices Development Tools are now available on the FDA website.

On the FDA website you can also find more details under Medical Device Development Tools (MDDT).

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