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

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...