CDRH Unveils Medical Device Innovation Pathway Bombarded by demands that it be more supportive of medical product innovation (see, for example, the next story), FDA in February announced its Medical ...

It appears that authors Anika Kumar and colleagues (November 2023) are potentially misinformed about the regulatory landscape in the US. According to the Food and Drug Administration (FDA), ...

Yesterday, the FDA announced in a press release that it is eyeing potential updates to the agency’s 510(k) clearance pathway for medical devices. These could include a requirement for more modern ...

MDDAP is a tailored version of the CMMI framework and provides a model and method by which medical device manufactures can better understand, measure, and improve their capability to develop high ...

The FDA should improve device safety by increasing the amount and availability of information about previously marketed ...