LINTHICUM HEIGHTS, MD – Sponsors interested in getting their medical device applications approved by the US Food and Drug Administration (FDA) should have robust design controls in place to ensure ...

But here is the uncomfortable truth that seasoned regulatory professionals already know and that ambitious founders are ...

The Food and Drug Administration (FDA) issued final guidance Monday that explains how medical device manufacturers can use a Predetermined Change Control Plan (PCCP) to update AI-enabled device ...

The US Food and Drug Administration (FDA) has issued four medical device-related guidance documents. The new guidances address brain-computer interfaces, considerations in medical device design for ...