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MDIC Digital Health Initiative Could Be Crucial To FDA Pre-Cert Program

The public-private partnership has launched an initiative that aims to help regulators address digital health – in particular the US FDA’s pre-cert pathway for certain medical software.

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• Source: Alamy

The Medical Device Innovation Consortium (MDIC) has a launched a Digital Health Initiative to work on issues related to digital health regulations. If fruitful, it could be key to developing the US Food and Drug Administration’s pre-certification (pre-cert) program, a relatively new product pathway for digital health devices.

The MDIC announced on 26 August it’s consolidating a number of initiatives, including its data science and technology, clinical science, and health economics and patient value initiatives. It will also work on the group’s National Evaluation System for Health Technology Coordinating Center (NESTcc), which is being funded by the FDA to develop a new postmarket real-world evidence data generation system

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