US goal to be “first” on devices worries former regulators

WASHINGTON (AP) — The head of the Food and Drug Administration’s device center was adamant: the U.S. would never cut corners to speed up product approvals.
In 2011, the FDA’s Dr. Jeffrey Shuren was repeatedly summoned before Congress. Lawmakers accused the agency of being too slow and too demanding in reviewing new devices. Each time, Shuren pushed back.
But in 2012, the FDA adopted a new approach: The agency would strive to be “first in the world” to approve device