6 questions for the medtech industry if Congress doesn’t reauthorize FDA user fees on time

MedTech Dive August 3, 2022
Elise Reuter

A failure to swiftly reauthorize user fees could slow the FDA’s ability to review medical devices and drugs.

Congress has until the end of September to reauthorize the Food and Drug Administration’s user fee programs. The package of legislation provides funding for reviewing devices, pharmaceuticals and other medical products over the next five years.

A version of the bill has passed the U.S. House of Representatives, but its equivalent has yet to pass the full U.S. Senate. As legislators prepare for their August recess, members of the House Energy and Commerce Committee have pressed the Senate to “act urgently” to meet its deadline.

Here’s what could happen if Congress is late.

1. Will the FDA really run out of...

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