
Qualifying Medical Device Development Tools (MDDT)
The US Food and Drug Administration (FDA)’s voluntary Qualification of Medical Device Development Tools (fda.gov) is intended to encourage use of innovative technologies and novel approaches to medical device development and create a favourable regulatory framework to expand the availability of entirely new medical devices to patients.
This blog includes an overview of MDDT program, its categories, history, benefits, Centre for Devices and Radiological Health (CDRH) Qualification Process and Decision Framework.
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