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 ...

On December 4, 2024, FDA finalized its guidance entitled “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions” ...

The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations ...

The US Food and Drug Administration (FDA) recently released draft guidance on the use of externally controlled clinical trials in determining the safety and efficacy of drug products. The topic ...

Three months in, most medical device manufacturers have completed their initial gap assessments — but the harder work is only ...