Scrutinizing the Downsides of FDA’s Fast-Track Approval: Risks and Legal Battles Unfold
WASHINGTON — Numerous medical products launched in the U.S. receive clearance through expedited Food and Drug Administration (FDA) processes, which have stirred controversy over their scrutiny of device safety and efficacy. Critics argue these processes are inadequately rigorous, often greenlighting devices too quickly without sufficient evaluation. The 510(k) Premarket Notification, a popular pathway for medical device approval, particularly attracts criticism. It allows devices to be approved based on similarity to previously approved devices without requiring new clinical safety and efficacy studies. Often, this process takes less than a year, raising concerns about the thoroughness of … Read more